[Federal Register Volume 62, Number 217 (Monday, November 10, 1997)]
[Rules and Regulations]
[Pages 60614-60632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29596]
[[Page 60613]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 16 and 900
Quality Mammography Standards; Correction; Final Rule
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 /
Rules and Regulations
[[Page 60614]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 900
[Docket No. 95N-0192]
RIN 0910-AA24
Quality Mammography Standards; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a
document entitled ``Quality Mammography Standards'' that appeared in
the Federal Register of October 28, 1997. The document was published
with some inadvertent typographical errors and incorrect dates in the
regulatory text. This document corrects those errors. FDA is also
identifying with greater specificity those sections of the quality
standards that will become effective October 28, 2002. For the
convenience of the reader, FDA is republishing 21 CFR part 900 in its
entirety with corrections.
DATES: This regulation is effective April 28, 1999; except
Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), (e)(5)(i)(B) which become
effective October 28, 2002.
FOR FURTHER INFORMATION CONTACT: Roger Burkhart, Center for Devices and
Radiological Health (HFZ-240), Food and Drug Administration 5600
Fishers Lane, Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.
SUPPLEMENTARY INFORMATION: In FR Doc. 97-26351, appearing on page 55852
in the Federal Register of Tuesday, October 28, 1997, the following
corrections are made:
1. On page 55852, in the first column, the ``DATES'' section is
corrected as set forth above.
2. On page 55854, in the first column, in the third full paragraph,
line 12, ``Mammography Matters'' should be italicized.
3. On page 55872, in the first column, in the fourth full
paragraph, in line 14, the ``+'' sign is corrected to read
``''.
4. On page 55895, in the second column, in the fifth paragraph, in
line 16, ``gi11'' is removed and the paragraph is indented at
``(Comment 225)''.
5. On page 55919, in the third column, in the fourth full
paragraph, in line 4, in the fifth full paragraph, in line 5, and in
the sixth full paragraph, in line 5, the ``+'' sign is corrected to
read ``''.
6. On page 55920, in the first column, in lines 1 and 6, the ``+''
sign is corrected to read ``''; and in the second column,
in the first full paragraph, in line 7, ``(10-4'' is corrected to read
``(10-4''.
7. On page 55930, in the second column, in the third line from the
bottom, the word ``patents'' is corrected to read ``patients''.
8. On page 55938, in the third column, in the second full
paragraph, in line 19, ``advided'' is corrected to read ``advised''.
9. On page 55954, in the first column, in the seventh paragraph,
beginning in line 6, ``Journal of the Medical Association'' should be
italicized.
10. On page 55967, in the first column, in the third line from the
bottom of the page, ``becauseit'' is corrected to read ``because it''.
11. On page 55975, in the second column, in the second full
paragraph, line 7, ``(C).'' is corrected to read ``. (C)''; and in the
third full paragraph, in line 4, ``(B).'' is corrected to read ``.
(B)''.
12. On page 55976, in the second column, in reference 5, in line 2,
``'' is corrected to read ``''; and in line 3,
``1995-1993'' is corrected to read ``1993-1995''.
Part 16 [Corrected]
13. On page 55976, in the authority citation for 21 CFR part 16,
``41-40'' is corrected to read ``40-41''; and in amendatory instruction
2., in the section heading, ``Sec. 716.1'' is corrected to read
``Sec. 16.1''.
Sec. 900.3 [Corrected]
14. On page 55979, in the second column in Sec. 900.3(c)(4), a
comma is inserted after ``July 28, 1998''.
Sec. 900.12 [Corrected]
15. On page 55986, in the first column, in the introductory text of
Sec. 900.12(a)(2)(iv), a comma is inserted after ``October 28, 1997''.
16. On page 55987, in the second column, in Sec. 900.12(b)(6)(ii)
the word ``valve'' is corrected to read ``value''; in
Sec. 900.12(b)(8)(i), ``October 28, 1999'' is corrected to read
``October 28, 2002''.
17. On page 55989, in the first column, in Sec. 900.12(e)(1)(ii),
(iii), (e)(2)(ii), and (e)(5)(ii) the ``+'' sign is corrected to read
``''; and in Sec. 900.12(e)(4)(iii)(B), (e)(5)(i)(B), and
(e)(5)(iii) ``October 28, 1999'' is corrected to read ``October 28,
2002'' each time it appears.
18. On page 55990, in the third column, in Sec. 900.12(e)(5)(x)(A),
``October 28, 1999'' is corrected to read ``October 28, 2002''.
19. On page 55991, in the third column, in Sec. 900.12(e)(12) the
``+'' sign is corrected to read ``''.
20. On page 55992, in the heading for Sec. 900.12(h), the word
``compliant'' is corrected to read ``complaint''.
Sec. 900.18 [Corrected]
21. On page 55993, in Sec. 900.18(a)(1), the word ``assuing'' is
corrected to read ``assuring''.
As corrected, 21 CFR part 900 is republished to read as follows:
PART 900--MAMMOGRAPHY
Subpart A--Accreditation
Sec.
900.1 Scope.
900.2 Definitions.
900.3 Application for approval as an accreditation body.
900.4 Standards for accreditation bodies.
900.5 Evaluation.
900.6 Withdrawal of approval.
900.7 Hearings.
900.8--900.9 [Reserved]
Subpart B--Quality Standards and Certification
900.10 Applicability.
900.11 Requirements for certification.
900.12 Quality standards.
900.13 Revocation of accreditation and revocation of accreditation
body approval.
900.14 Suspension or revocation of certificates.
900.15 Appeals of adverse accreditation or reaccreditation
decisions that preclude certification or recertification.
900.16 Appeals of denials of certification.
900.17 [Reserved]
900.18 Alternative requirements for Sec. 900.12 quality standards.
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
Subpart A--Accreditation
Sec. 900.1 Scope.
The regulations set forth in this part implement the Mammography
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part
establishes procedures whereby an entity can apply to become a Food and
Drug Administration (FDA)-approved accreditation body to accredit
facilities to be eligible to perform screening or diagnostic
mammography services. Subpart A further establishes requirements and
standards for accreditation bodies to ensure that all mammography
facilities under the jurisdiction of the United States are adequately
and consistently evaluated for compliance with national quality
standards for mammography. Subpart B of this part establishes minimum
national quality standards for mammography facilities to ensure safe,
reliable, and accurate mammography. The regulations set forth in this
part do
[[Page 60615]]
not apply to facilities of the Department of Veterans Affairs.
Sec. 900.2 Definitions.
The following definitions apply to subparts A and B of this part:
(a) Accreditation body or body means an entity that has been
approved by FDA under Sec. 900.3(d) to accredit mammography facilities.
(b) Action limits or action levels means the minimum and maximum
values of a quality assurance measurement that can be interpreted as
representing acceptable performance with respect to the parameter being
tested. Values less than the minimum or greater than the maximum action
limit or level indicate that corrective action must be taken by the
facility. Action limits or levels are also sometimes called control
limits or levels.
(c) Adverse event means an undesirable experience associated with
mammography activities within the scope of 42 U.S.C. 263b. Adverse
events include but are not limited to:
(1) Poor image quality;
(2) Failure to send mammography reports within 30 days to the
referring physician or in a timely manner to the self-referred patient;
and
(3) Use of personnel that do not meet the applicable requirements
of Sec. 900.12(a).
(d) Air kerma means kerma in a given mass of air. The unit used to
measure the quantity of air kerma is the Gray (Gy). For X-rays with
energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 radian (rad)
= 114 roentgens (R) of exposure.
(e) Breast implant means a prosthetic device implanted in the
breast.
(f) Calendar quarter means any one of the following time periods
during a given year: January 1 through March 31, April 1 through June
30, July 1 through September 30, or October 1 through December 31.
(g) Category I means medical educational activities that have been
designated as Category I by the Accreditation Council for Continuing
Medical Education (ACCME), the American Osteopathic Association (AOA),
a state medical society, or an equivalent organization.
(h) Certificate means the certificate described in Sec. 900.11(a).
(i) Certification means the process of approval of a facility by
FDA to provide mammography services.
(j) Clinical image means a mammogram.
(k) Consumer means an individual who chooses to comment or complain
in reference to a mammography examination, including the patient or
representative of the patient (e.g., family member or referring
physician).
(l) Continuing education unit or continuing education credit means
one contact hour of training.
(m) Contact hour means an hour of training received through direct
instruction.
(n) Direct instruction means:
(1) Face-to-face interaction between instructor(s) and student(s),
as when the instructor provides a lecture, conducts demonstrations, or
reviews student performance; or
(2) The administration and correction of student examinations by an
instructor(s) with subsequent feedback to the student(s).
(o) Direct supervision means that:
(1) During joint interpretation of mammograms, the supervising
interpreting physician reviews, discusses, and confirms the diagnosis
of the physician being supervised and signs the resulting report before
it is entered into the patient's records; or
(2) During the performance of a mammography examination or survey
of the facility's equipment and quality assurance program, the
supervisor is present to observe and correct, as needed, the
performance of the individual being supervised who is performing the
examination or conducting the survey.
(p) Established operating level means the value of a particular
quality assurance parameter that has been established as an acceptable
normal level by the facility's quality assurance program.
(q) Facility means a hospital, outpatient department, clinic,
radiology practice, mobile unit, office of a physician, or other
facility that conducts mammography activities, including the following:
Operation of equipment to produce a mammogram, processing of the
mammogram, initial interpretation of the mammogram, and maintaining
viewing conditions for that interpretation. This term does not include
a facility of the Department of Veterans Affairs.
(r) First allowable time means the earliest time a resident
physician is eligible to take the diagnostic radiology boards from an
FDA-designated certifying body. The ``first allowable time'' may vary
with the certifying body.
(s) FDA means the Food and Drug Administration.
(t) Interim regulations means the regulations entitled
``Requirements for Accrediting Bodies of Mammography Facilities'' (58
FR 67558-67565) and ``Quality Standards and Certification Requirements
for Mammography Facilities'' (58 FR 67565-67572), published by FDA on
December 21, 1993, and amended on September 30, 1994 (59 FR 49808-
49813). These regulations established the standards that had to be met
by mammography facilities in order to lawfully operate between October
1, 1994, and April 28, 1999.
(u) Interpreting physician means a licensed physician who
interprets mammograms and who meets the requirements set forth in
Sec. 900.12(a)(1).
(v) Kerma means the sum of the initial energies of all the charged
particles liberated by uncharged ionizing particles in a material of
given mass.
(w) Laterality means the designation of either the right or left
breast.
(x) Lead interpreting physician means the interpreting physician
assigned the general responsibility for ensuring that a facility's
quality assurance program meets all of the requirements of
Sec. 900.12(d) through (f). The administrative title and other
supervisory responsibilities of the individual, if any, are left to the
discretion of the facility.
(y) Mammogram means a radiographic image produced through
mammography.
(z) Mammographic Modality means a technology, within the scope of
42 U.S.C. 263b, for radiography of the breast. Examples are screen-film
mammography and xeromammography.
(aa) Mammography means radiography of the breast, but, for the
purposes of this part, does not include:
(1) Radiography of the breast performed during invasive
interventions for localization or biopsy procedures; or
(2) Radiography of the breast performed with an investigational
mammography device as part of a scientific study conducted in
accordance with FDA's investigational device exemption regulations in
part 812 of this chapter.
(bb) Mammography equipment evaluation means an onsite assessment of
mammography unit or image processor performance by a medical physicist
for the purpose of making a preliminary determination as to whether the
equipment meets all of the applicable standards in Sec. 900.12(b) and
(e).
(cc) Mammography medical outcomes audit means a systematic
collection of mammography results and the comparison of those results
with outcomes data.
(dd) Mammography unit or units means an assemblage of components
for the production of X-rays for use during mammography, including, at
a minimum: An X-ray generator, an X-ray
[[Page 60616]]
control, a tube housing assembly, a beam limiting device, and the
supporting structures for these components.
(ee) Mean optical density means the average of the optical
densities measured using phantom thicknesses of 2, 4, and 6 centimeters
with values of kilovolt peak (kVp) clinically appropriate for those
thicknesses.
(ff) Medical physicist means a person trained in evaluating the
performance of mammography equipment and facility quality assurance
programs and who meets the qualifications for a medical physicist set
forth in Sec. 900.12(a)(3).
(gg) MQSA means the Mammography Quality Standards Act.
(hh) Multi-reading means two or more physicians, at least one of
whom is an interpreting physician, interpreting the same mammogram.
(ii) Patient means any individual who undergoes a mammography
evaluation in a facility, regardless of whether the person is referred
by a physician or is self-referred.
(jj) Phantom means a test object used to simulate radiographic
characteristics of compressed breast tissue and containing components
that radiographically model aspects of breast disease and cancer.
(kk) Phantom image means a radiographic image of a phantom.
(ll) Physical science means physics, chemistry, radiation science
(including medical physics and health physics), and engineering.
(mm) Positive mammogram means a mammogram that has an overall
assessment of findings that are either ``suspicious'' or ``highly
suggestive of malignancy.''
(nn) Provisional certificate means the provisional certificate
described in Sec. 900.11(b)(2).
(oo) Qualified instructor means an individual whose training and
experience adequately prepares him or her to carry out specified
training assignments. Interpreting physicians, radiologic
technologists, or medical physicists who meet the requirements of
Sec. 900.12(a) would be considered qualified instructors in their
respective areas of mammography. Other examples of individuals who may
be qualified instructors for the purpose of providing training to meet
the regulations of this part include, but are not limited to,
instructors in a post-high school training institution and
manufacturer's representatives.
(pp) Quality control technologist means an individual meeting the
requirements of Sec. 900.12(a)(2) who is responsible for those quality
assurance responsibilities not assigned to the lead interpreting
physician or to the medical physicist.
(qq) Radiographic equipment means X-ray equipment used for the
production of static X-ray images.
(rr) Radiologic technologist means an individual specifically
trained in the use of radiographic equipment and the positioning of
patients for radiographic examinations and who meets the requirements
set forth in Sec. 900.12(a)(2).
(ss) Serious adverse event means an adverse advent that may
significantly compromise clinical outcomes, or an adverse event for
which a facility fails to take appropriate corrective action in a
timely manner.
(tt) Serious complaint means a report of a serious adverse event.
(uu) Standard breast means a 4.2 centimeter (cm) thick compressed
breast consisting of 50 percent glandular and 50 percent adipose
tissue.
(vv) Survey means an onsite physics consultation and evaluation of
a facility quality assurance program performed by a medical physicist.
(ww) Time cycle means the film development time.
(xx) Traceable to a national standard means an instrument is
calibrated at either the National Institute of Standards and Technology
(NIST) or at a calibration laboratory that participates in a
proficiency program with NIST at least once every 2 years and the
results of the proficiency test conducted within 24 months of
calibration show agreement within 3 percent of the
national standard in the mammography energy range.
Sec. 900.3 Application for approval as an accreditation body.
(a) Eligibility. Private nonprofit organizations or State agencies
capable of meeting the requirements of this subpart A may apply for
approval as accreditation bodies.
(b) Application for initial approval. (1) An applicant seeking
initial FDA approval as an accreditation body shall inform the Division
of Mammography Quality and Radiation Programs (DMQRP), Center for
Devices and Radiology Health (HFZ-240), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography
Standards Branch, of its desire to be approved as an accreditation body
and of its requested scope of authority.
(2) Following receipt of the request, FDA will provide the
applicant with additional information to aid in submission of an
application for approval as an accreditation body.
(3) The applicant shall furnish to FDA, at the address in
Sec. 900.3(b)(1), three copies of an application containing the
following information, materials, and supporting documentation:
(i) Name, address, and phone number of the applicant and, if the
applicant is not a State agency, evidence of nonprofit status (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit
organization);
(ii) Detailed description of the accreditation standards the
applicant will require facilities to meet and a discussion
substantiating their equivalence to FDA standards required under
Sec. 900.12;
(iii) Detailed description of the applicant's accreditation review
and decisionmaking process, including:
(A) Procedures for performing accreditation and reaccreditation
clinical image review in accordance with Sec. 900.4(c), random clinical
image reviews in accordance with Sec. 900.4(f), and additional
mammography review in accordance with Sec. 900.12(j);
(B) Procedures for performing phantom image review;
(C) Procedures for assessing mammography equipment evaluations and
surveys;
(D) Procedures for initiating and performing onsite visits to
facilities;
(E) Procedures for assessing facility personnel qualifications;
(F) Copies of the accreditation application forms, guidelines,
instructions, and other materials the applicant will send to facilities
during the accreditation process, including an accreditation history
form that requires each facility to provide a complete history of prior
accreditation activities and a statement that all information and data
submitted in the application is true and accurate, and that no material
fact has been omitted;
(G) Policies and procedures for notifying facilities of
deficiencies;
(H) Procedures for monitoring corrections of deficiencies by
facilities;
(I) Policies and procedures for suspending or revoking a facility's
accreditation;
(J) Policies and procedures that will ensure processing of
accreditation applications and renewals within a timeframe approved by
FDA and assurances that the body will adhere to such policies and
procedures; and
(K) A description of the applicant's appeals process for facilities
contesting adverse accreditation status decisions.
(iv) Education, experience, and training requirements for the
applicant's professional staff, including reviewers of clinical or
phantom images;
(v) Description of the applicant's electronic data management and
[[Page 60617]]
analysis system with respect to accreditation review and decision
processes and the applicant's ability to provide electronic data in a
format compatible with FDA data systems;
(vi) Resource analysis that demonstrates that the applicant's
staffing, funding, and other resources are adequate to perform the
required accreditation activities;
(vii) Fee schedules with supporting cost data;
(viii) Statement of policies and procedures established to avoid
conflicts of interest or the appearance of conflicts of interest by the
applicant's board members, commissioners, professional personnel
(including reviewers of clinical and phantom images), consultants,
administrative personnel, and other representatives of the applicant;
(ix) Statement of policies and procedures established to protect
confidential information the applicant will collect or receive in its
role as an accreditation body;
(x) Disclosure of any specific brand of imaging system or
component, measuring device, software package, or other commercial
product used in mammography that the applicant develops, sells, or
distributes;
(xi) Description of the applicant's consumer complaint mechanism;
(xii) Satisfactory assurances that the applicant shall comply with
the requirements of Sec. 900.4; and
(xiii) Any other information as may be required by FDA.
(c) Application for renewal of approval. An approved accreditation
body that intends to continue to serve as an accreditation body beyond
its current term shall apply to FDA for renewal or notify FDA of its
plans not to apply for renewal in accordance with the following
procedures and schedule:
(1) At least 9 months before the date of expiration of a body's
approval, the body shall inform FDA, at the address given in
Sec. 900.3(b)(1), of its intent to seek renewal.
(2) FDA will notify the applicant of the relevant information,
materials, and supporting documentation required under Sec. 900.3(b)(3)
that the applicant shall submit as part of the renewal procedure.
(3) At least 6 months before the date of expiration of a body's
approval, the applicant shall furnish to FDA, at the address in
Sec. 900.3(b)(1), three copies of a renewal application containing the
information, materials, and supporting documentation requested by FDA
in accordance with Sec. 900.3(c)(2).
(4) No later than July 28, 1998, any accreditation body approved
under the interim regulations published in the Federal Register of
December 21, 1993 (58 FR 67558), that desires to continue to serve as
an accreditation body under the final regulations shall apply for
renewal of approval in accordance with the procedures set forth in
paragraphs (c)(1) through (c)(3) of this section.
(5) Any accreditation body that does not plan to renew its approval
shall so notify FDA at the address given in paragraph (b)(1) of this
section at least 9 months before the expiration of the body's term of
approval.
(d) Rulings on applications for initial and renewed approval. (1)
FDA will conduct a review and evaluation to determine whether the
applicant substantially meets the applicable requirements of this
subpart and whether the accreditation standards the applicant will
require facilities to meet are substantially the same as the quality
standards published under subpart B of this part.
(2) FDA will notify the applicant of any deficiencies in the
application and request that those deficiencies be rectified within a
specified time period. If the deficiencies are not rectified to FDA's
satisfaction within the specified time period, the application for
approval as an accreditation body may be rejected.
(3) FDA shall notify the applicant whether the application has been
approved or denied. That notification shall list any conditions
associated with approval or state the bases for any denial.
(4) The review of any application may include a meeting between FDA
and representatives of the applicant at a time and location mutually
acceptable to FDA and the applicant.
(5) FDA will advise the applicant of the circumstances under which
a denied application may be resubmitted.
(6) If FDA does not reach a final decision on a renewal application
in accordance with this paragraph before the expiration of an
accreditation body's current term of approval, the approval will be
deemed extended until the agency reaches a final decision on the
application, unless an accreditation body does not rectify deficiencies
in the application within the specified time period, as required in
paragraph (d)(2) of this section.
(e) Relinquishment of authority. An accreditation body that decides
to relinquish its accreditation authority before expiration of the
body's term of approval shall submit a letter of such intent to FDA, at
the address in Sec. 900.3(b)(1), at least 9 months before relinquishing
such authority.
(f) Transfer of records. An accreditation body that does not apply
for renewal of accreditation body approval, is denied such approval by
FDA, or relinquishes its accreditation authority and duties before
expiration of its term of approval, shall:
(1) Transfer facility records and other related information as
required by FDA to a location and according to a schedule approved by
FDA.
(2) Notify, in a manner and time period approved by FDA, all
facilities accredited or seeking accreditation by the body that the
body will no longer have accreditation authority.
(g) Scope of authority. An accreditation body's term of approval is
for a period not to exceed 7 years. FDA may limit the scope of
accreditation authority.
Sec. 900.4 Standards for accreditation bodies.
(a) Code of conduct and general responsibilities. The accreditation
body shall accept the following responsibilities in order to ensure
safe and accurate mammography at the facilities it accredits and shall
perform these responsibilities in a manner that ensures the integrity
and impartiality of accreditation body actions.
(1)(i) When an accreditation body receives or discovers information
that suggests inadequate image quality, or upon request by FDA, the
accreditation body shall review a facility's clinical images or other
aspects of a facility's practice to assist FDA in determining whether
or not the facility's practice poses a serious risk to human health.
Such reviews are in addition to the evaluation an accreditation body
performs as part of the initial accreditation or renewal process for
facilities.
(ii) If review by the accreditation body demonstrates that a
problem does exist with respect to image quality or other aspects of a
facility's compliance with quality standards, or upon request by FDA,
the accreditation body shall require or monitor corrective actions, or
suspend or revoke accreditation of the facility.
(2) The accreditation body shall inform FDA as soon as possible but
in no case longer than 2 business days after becoming aware of
equipment or practices that pose a serious risk to human health.
(3) The accreditation body shall establish and administer a quality
assurance (QA) program that has been approved by FDA in accordance with
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality
assurance program shall:
[[Page 60618]]
(i) Include requirements for clinical image review and phantom
image review;
(ii) Ensure that clinical and phantom images are evaluated
consistently and accurately; and
(iii) Specify the methods and frequency of training and evaluation
for clinical and phantom image reviewers, and the bases and procedures
for removal of such reviewers.
(4) The accreditation body shall establish measures that FDA has
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this
section to reduce the possibility of conflict of interest or facility
bias on the part of individuals acting on the body's behalf. Such
individuals who review clinical or phantom images under the provisions
of paragraphs (c) and (d) of this section or who visit facilities under
the provisions of paragraph (f) of this section shall not review
clinical or phantom images from or visit a facility with which such
individuals maintain a financial relationship, or when it would
otherwise be a conflict of interest for them to do so, or when they
have a bias in favor of or against the facility.
(5) The accreditation body may require specific equipment
performance or design characteristics that FDA has approved. However,
no accreditation body shall require, either explicitly or implicitly,
the use of any specific brand of imaging system or component, measuring
device, software package, or other commercial product as a condition
for accreditation by the body, unless FDA determines that it is in the
best interest of public health to do so.
(i) Any representation, actual or implied, either orally, in sales
literature, or in any other form of representation, that the purchase
or use of a particular product brand is required in order for any
facility to be accredited or certified under Sec. 900.11(b), is
prohibited, unless FDA approves such representation.
(ii) Unless FDA has approved the exclusive use and promotion of a
particular commercial product in accordance with this section, all
products produced, distributed, or sold by an accreditation body or an
organization that has a financial or other relationship with the
accreditation body that may be a conflict of interest or have the
appearance of a conflict of interest with the body's accreditation
functions, shall bear a disclaimer stating that the purchase or use of
such products is not required for accreditation or certification of any
facility under Sec. 900.11(b). Any representations about such products
shall include a similar disclaimer.
(6) When an accreditation body denies accreditation to a facility,
the accreditation body shall notify the facility in writing and explain
the bases for its decision. The notification shall also describe the
appeals process available from the accreditation body for the facility
to contest the decision.
(7) No accreditation body may establish requirements that preclude
facilities from being accredited under Sec. 900.11(b) by any other
accreditation body, or require accreditation by itself under MQSA if
another accreditation body is available to a facility.
(8) The accreditation body shall obtain FDA authorization for any
changes it proposes to make in any standards that FDA has previously
accepted under Sec. 900.3(d).
(9) An accreditation body shall establish procedures to protect
confidential information it collects or receives in its role as an
accreditation body.
(i) Nonpublic information collected from facilities for the purpose
of carrying out accreditation body responsibilities shall not be used
for any other purpose or disclosed, other than to FDA or its duly
designated representatives, including State agencies, without the
consent of the facility;
(ii) Nonpublic information that FDA or its duly designated
representatives, including State agencies, share with the accreditation
body concerning a facility that is accredited or undergoing
accreditation by that body shall not be further disclosed except with
the written permission of FDA.
(b) Monitoring facility compliance with quality standards. (1) The
accreditation body shall require that each facility it accredits meet
standards for the performance of quality mammography that are
substantially the same as those in this subpart and in subpart B of
this part.
(2) The accreditation body shall notify a facility regarding
equipment, personnel, and other aspects of the facility's practice that
do not meet such standards and advise the facility that such equipment,
personnel, or other aspects of the practice should not be used by the
facility for activities within the scope of part 900.
(3) The accreditation body shall specify the actions that
facilities shall take to correct deficiencies in equipment, personnel,
and other aspects of the practice to ensure facility compliance with
applicable standards.
(4) If deficiencies cannot be corrected to ensure compliance with
standards or if a facility is unwilling to take corrective actions, the
accreditation body shall immediately so notify FDA, and shall suspend
or revoke the facility's accreditation in accordance with the policies
and procedures described under Sec. 900.3(b)(3)(iii)(I).
(c) Clinical image review for accreditation and reaccreditation.
(1) Frequency of review. The accreditation body shall review clinical
images from each facility accredited by the body at least once every 3
years.
(2) Requirements for clinical image attributes. The accreditation
body shall use the following attributes for all clinical image reviews,
unless FDA has approved other attributes:
(i) Positioning. Sufficient breast tissue shall be imaged to ensure
that cancers are not likely to be missed because of inadequate
positioning.
(ii) Compression. Compression shall be applied in a manner that
minimizes the potential obscuring effect of overlying breast tissue and
motion artifact.
(iii) Exposure level. Exposure level shall be adequate to visualize
breast structures. Images shall be neither underexposed nor
overexposed.
(iv) Contrast. Image contrast shall permit differentiation of
subtle tissue density differences.
(v) Sharpness. Margins of normal breast structures shall be
distinct and not blurred.
(vi) Noise. Noise in the image shall not obscure breast structures
or suggest the appearance of structures not actually present.
(vii) Artifacts. Artifacts due to lint, processing, scratches, and
other factors external to the breast shall not obscure breast
structures or suggest the appearance of structures not actually
present.
(viii) Examination identification. Each image shall have the
following information indicated on it in a permanent, legible, and
unambiguous manner and placed so as not to obscure anatomic structures:
(A) Name of the patient and an additional patient identifier.
(B) Date of examination.
(C) View and laterality. This information shall be placed on the
image in a position near the axilla. Standardized codes specified by
the accreditation body and approved by FDA in accordance with
Sec. 900.3(d) or paragraph (a)(8) of this section shall be used to
identify view and laterality.
(D) Facility name and location. At a minimum, the location shall
include the city, State, and zip code of the facility.
(E) Technologist identification.
(F) Cassette/screen identification.
(G) Mammography unit identification, if there is more than one unit
in the facility.
[[Page 60619]]
(3) Scoring of clinical images. Accreditation bodies shall
establish and administer a system for scoring clinical images using all
attributes specified in paragraphs (c)(2)(i) through (c)(2)(viii) of
this section or an alternative system that FDA has approved in
accordance with Sec. 900.3(d) or paragraph (a)(8) of this section. The
scoring system shall include an evaluation for each attribute.
(i) The accreditation body shall establish and employ criteria for
acceptable and nonacceptable results for each of the 8 attributes as
well as an overall pass-fail system for clinical image review that has
been approved by FDA in accordance with Sec. 900.3(d) or paragraph
(a)(8) of this section.
(ii) All clinical images submitted by a facility to the
accreditation body shall be reviewed independently by two or more
clinical image reviewers.
(4) Selection of clinical images for review. Unless otherwise
specified by FDA, the accreditation body shall require that for each
mammography unit in the facility:
(i) The facility shall submit craniocaudal (CC) and mediolateral
oblique (MLO) views from two mammographic examinations that the
facility produced during a time period specified by the accreditation
body;
(ii) Clinical images submitted from one such mammographic
examination for each unit shall be of dense breasts (predominance of
glandular tissue) and the other shall be of fat-replaced breasts
(predominance of adipose tissue);
(iii) All clinical images submitted shall be images that the
facility's interpreting physician(s) interpreted as negative or benign.
(iv) If the facility has no clinical images meeting the
requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this
section, it shall so notify the accreditation body, which shall specify
alternative clinical image selection methods that do not compromise
care of the patient.
(5) Clinical image reviewers. Accreditation bodies shall ensure
that all of their clinical image reviewers:
(i) Meet the interpreting physician requirements specified in
Sec. 900.12(a)(1);
(ii) Are trained and evaluated in the clinical image review
process, for the types of clinical images to be evaluated by a clinical
image reviewer, by the accreditation body before designation as
clinical image reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any clinical image and provide information to the
facility for use in improving the attributes for which significant
deficiencies were identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to ensure the security and return to the
facility of all clinical images received and to ensure completion of
all clinical image reviews by the body in a timely manner. The
accreditation body shall return all clinical images to the facility
within 60 days of their receipt by the body, with the following
exceptions:
(i) If the clinical images are needed earlier by the facility for
clinical purposes, the accreditation body shall cooperate with the
facility to accommodate such needs.
(ii) If a clinical image reviewer identifies a suspicious
abnormality on an image submitted for clinical image review, the
accreditation body shall ensure that this information is provided to
the facility and that the clinical images are returned to the facility.
Both shall occur no later than 10 business days after identification of
the suspected abnormality.
(7) Notification of unsatisfactory image quality. If the
accreditation body determines that the clinical images received from a
facility are of unsatisfactory quality, the body shall notify the
facility of the nature of the problem and its possible causes.
(d) Phantom image review for accreditation and reaccreditation.
(1) Frequency of review. The accreditation body shall review phantom
images from each facility accredited by the body at least once every 3
years.
(2) Requirements for the phantom used. The accreditation body shall
require that each facility submit for review phantom images that the
facility produced using a phantom and methods of use specified by the
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph
(a)(8) of this section.
(3) Scoring phantom images. The accreditation body shall use a
system for scoring phantom images that has been approved by FDA in
accordance with Sec. 900.3(b) and (d) or paragraph (a)(8) of this
section.
(4) Phantom images selected for review. For each mammography unit
in the facility, the accreditation body shall require the facility to
submit phantom images that the facility produced during a time period
specified by the body.
(5) Phantom image reviewers. Accreditation bodies shall ensure that
all of their phantom image reviewers:
(i) Meet the requirements specified in Sec. 900.12(a)(3) or
alternative requirements established by the accreditation body and
approved by FDA in accordance with Sec. 900.3 or paragraph (a)(8) of
this section;
(ii) Are trained and evaluated in the phantom image review process,
for the types of phantom images to be evaluated by a phantom image
reviewer, by the accreditation body before designation as phantom image
reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any phantom image and provide information to the
facility for use in improving its phantom image quality with regard to
the significant deficiencies identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to ensure the security of all phantom images
received and to ensure completion of all phantom image reviews by the
body in a timely manner. All phantom images that result in a failure of
accreditation shall be returned to the facility.
(7) Notification measures for unsatisfactory image quality. If the
accreditation body determines that the phantom images received from a
facility are of unsatisfactory quality, the body shall notify the
facility of the nature of the problem and its possible causes.
(e) Reports of mammography equipment evaluation, surveys, and
quality control. The following requirements apply to all facility
equipment covered by the provisions of subparts A and B:
(1) The accreditation body shall require every facility applying
for accreditation to submit:
(i) With its initial accreditation application, a mammography
equipment evaluation that was performed by a medical physicist no
earlier than 6 months before the date of application for accreditation
by the facility. Such evaluation shall demonstrate compliance of the
facility's equipment with the requirements in Sec. 900.12(e).
(ii) Prior to accreditation, a survey that was performed no earlier
than 6 months before the date of application for accreditation by the
facility. Such survey shall assess the facility's compliance with the
facility standards referenced in paragraph (b) of this section.
(2) The accreditation body shall require that all facilities
undergo an annual survey to ensure continued compliance with the
standards referenced in paragraph (b) of this section and to provide
continued oversight of facilities' quality control programs as they
relate to such standards. The accreditation body shall require for all
facilities that:
(i) Such surveys be conducted annually;
[[Page 60620]]
(ii) Facilities take reasonable steps to ensure that they receive
reports of such surveys within 30 days of survey completion; and
(iii) Facilities submit the results of such surveys and any other
information that the body may require to the body at least annually.
(3) The accreditation body shall review and analyze the information
required in this section and use it to identify necessary corrective
measures for facilities and to determine whether facilities should
remain accredited by the body.
(f) Accreditation Body Onsite Visits and Random Clinical Image
Reviews. The accreditation body shall conduct onsite visits and random
clinical image reviews of a sample of facilities to monitor and assess
their compliance with standards established by the body for
accreditation. The accreditation body shall submit annually to FDA, at
the address given in Sec. 900.3(b)(1), 3 copies of a summary report
describing all facility assessments the body conducted under the
provisions of this section for the year being reported.
(1) Onsite visits. (i) Sample size. Annually, each accreditation
body shall visit at least 5 percent of the facilities it accredits.
However, a minimum of 5 facilities shall be visited, and visits to no
more than 50 facilities are required, unless problems identified in
paragraph (f)(1)(i)(B) of this section indicate a need to visit more
than 50 facilities.
(A) At least 50 percent of the facilities visited shall be selected
randomly.
(B) Other facilities visited shall be selected based on problems
identified through State or FDA inspections, serious complaints
received from consumers or others, a previous history of noncompliance,
or any other information in the possession of the accreditation body,
inspectors, or FDA.
(C) Before, during, or after any facility visit, the accreditation
body may require that the facility submit to the body for review
clinical images, phantom images, or any other information relevant to
applicable standards in this subpart and in subpart B of this part.
(ii) Visit plan. The accreditation body shall conduct facility
onsite visits according to a visit plan that has been approved by FDA
in accordance with Sec. 900.3(d) or paragraph (a)(8) of this section,
unless otherwise directed by FDA in particular circumstances. At a
minimum, such a plan shall provide for:
(A) Assessment of overall clinical image QA activities of the
facility;
(B) Review of facility documentation to determine if appropriate
mammography reports are sent to patients and physicians as required;
(C) Selection of a sample of clinical images for clinical image
review by the accreditation body. Clinical images shall be selected in
a manner specified by the accreditation body and approved by FDA that
does not compromise care of the patient as a result of the absence of
the selected images from the facility;
(D) Verification that the facility has a medical audit system in
place and is correlating films and pathology reports for positive
cases;
(E) Verification that personnel specified by the facility are the
ones actually performing designated personnel functions;
(F) Verification that equipment specified by the facility is the
equipment that is actually being used to perform designated equipment
functions;
(G) Verification that a consumer complaint mechanism is in place
and that the facility is following its procedures; and
(H) Review of all factors related to previously identified concerns
or concerns identified during that visit.
(2) Clinical image review for random sample of facilities. (i)
Sample size. In addition to conducting clinical image reviews for
accreditation and reaccreditation for all facilities, the accreditation
body shall conduct clinical image reviews annually for a randomly
selected sample as specified by FDA, but to include at least 3 percent
of the facilities the body accredits. Accreditation bodies may count
toward this random sample requirement all facilities selected randomly
for the onsite visits described in paragraph (f)(1)(i)(A) of this
section. Accreditation bodies shall not count toward the random sample
requirement any facilities described in paragraph (f)(1)(i)(B) of this
section that were selected for a visit because of previously identified
concerns.
(ii) Random clinical image review. In performing clinical image
reviews of the random sample of facilities, accreditation bodies shall
evaluate the same attributes as those in paragraph (c) of this section
for review of clinical images for accreditation and reaccreditation.
(iii) Accreditation bodies should not schedule random clinical
image reviews at facilities that have received notification of the need
to begin the accreditation renewal process or that have completed the
accreditation renewal process within the previous 6 months.
(iv) Selection of the random sample of clinical images for clinical
image review by the accreditation body. Clinical images shall be
selected in a manner, specified by the accreditation body and approved
by FDA under Sec. 900.3(d) or paragraph (a)(8) of this section, that
does not compromise care of the patient as a result of the absence of
the selected images from the facility.
(g) Consumer complaint mechanism. The accreditation body shall
develop and administer a written and documented system, including
timeframes, for collecting and resolving serious consumer complaints
that could not be resolved at a facility. Such system shall have been
approved by FDA in accordance withSec. 900.3(d) or paragraph (a)(8) of
this section. Accordingly, all accreditation bodies shall:
(1) Provide a mechanism for all facilities it accredits to file
serious unresolved complaints with the accreditation body;
(2) Maintain a record of every serious unresolved complaint
received by the body on all facilities it accredits for a period of at
least 3 years from the date of receipt of each such complaint;
(h) Reporting and recordkeeping. All reports to FDA specified in
paragraphs (h)(1) through (h)(4) of this section shall be prepared and
submitted in a format and medium prescribed by FDA and shall be
submitted to a location and according to a schedule specified by FDA.
The accreditation body shall:
(1) Collect and submit to FDA the information required by 42 U.S.C.
263b(d) for each facility when the facility is initially accredited and
at least annually when updated, in a manner and at a time specified by
FDA.
(2) Accept applications containing the information required in 42
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.11(b)(3)
for extension of provisional certificates, on behalf of FDA, and notify
FDA of the receipt of such information;
(3) Submit to FDA the name, identifying information, and other
information relevant to 42 U.S.C. 263b and specified by FDA for any
facility for which the accreditation body denies, suspends, or revokes
accreditation, and the reason(s) for such action;
(4) Submit to FDA an annual report summarizing all serious
complaints received during the previous calendar year, their resolution
status, and any actions taken in response to them;
(5) Provide to FDA other information relevant to 42 U.S.C. 263b and
required by FDA about any facility accredited or undergoing
accreditation by the body.
(i) Fees. Fees charged to facilities for accreditation shall be
reasonable. Costs of accreditation body activities that are not related
to accreditation functions under 42 U.S.C. 263b are not
[[Page 60621]]
recoverable through fees established for accreditation.
(1) The accreditation body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different facilities.
(2) At FDA's request, accreditation bodies shall provide financial
records or other material to assist FDA in assessing the reasonableness
of accreditation body fees. Such material shall be provided to FDA in a
manner and time period specified by the agency.
Sec. 900.5 Evaluation.
FDA shall evaluate annually the performance of each accreditation
body. Such evaluation shall include an assessment of the reports of FDA
or State inspections of facilities accredited by the body as well as
any additional information deemed relevant by FDA that has been
provided by the accreditation body or other sources or has been
required by FDA as part of its oversight initiatives. The evaluation
shall include a determination of whether there are major deficiencies
in the accreditation body's performance that, if not corrected, would
warrant withdrawal of the approval of the accreditation body under the
provisions of Sec. 900.6.
Sec. 900.6 Withdrawal of approval.
If FDA determines, through the evaluation activities of Sec. 900.5,
or through other means, that an accreditation body is not in
substantial compliance with this subpart, FDA may initiate the
following actions:
(a) Major deficiencies. If FDA determines that an accreditation
body has failed to perform a major accreditation function
satisfactorily, has demonstrated willful disregard for public health,
has violated the code of conduct, has committed fraud, or has submitted
material false statements to the agency, FDA may withdraw its approval
of that accreditation body.
(1) FDA shall notify the accreditation body of the agency's action
and the grounds on which the approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify
facilities accredited or seeking accreditation by it that its approval
has been withdrawn. Such notification shall be made within a time
period and in a manner approved by FDA.
(b) Minor deficiencies. If FDA determines that an accreditation
body has demonstrated deficiencies in performing accreditation
functions and responsibilities that are less serious or more limited
than the deficiencies in paragraph (a) of this section, FDA shall
notify the body that it has a specified period of time to take
particular corrective measures directed by FDA or to submit to FDA for
approval the body's own plan of corrective action addressing the minor
deficiencies. FDA may place the body on probationary status for a
period of time determined by FDA, or may withdraw approval of the body
as an accreditation body if corrective action is not taken.
(1) If FDA places an accreditation body on probationary status, the
body shall notify all facilities accredited or seeking accreditation by
it of its probationary status within a time period and in a manner
approved by FDA.
(2) Probationary status shall remain in effect until such time as
the body can demonstrate to the satisfaction of FDA that it has
successfully implemented or is implementing the corrective action plan
within the established schedule, and that the corrective actions have
substantially eliminated all identified problems.
(3) If FDA determines that an accreditation body that has been
placed on probationary status is not implementing corrective actions
satisfactorily or within the established schedule, FDA may withdraw
approval of the accreditation body. The accreditation body shall notify
all facilities accredited or seeking accreditation by it of its loss of
FDA approval, within a time period and in a manner approved by FDA.
(c) Reapplication by accreditation bodies that have had their
approval withdrawn. (1) A former accreditation body that has had its
approval withdrawn may submit a new application for approval if the
body can provide information to FDA to establish that the problems that
were grounds for withdrawal of approval have been resolved.
(2) If FDA determines that the new application demonstrates that
the body satisfactorily has addressed the causes of its previous
unacceptable performance, FDA may reinstate approval of the
accreditation body.
(3) FDA may request additional information or establish additional
conditions that must be met by a former accreditation body before FDA
approves the reapplication.
(4) FDA may refuse to accept an application from a former
accreditation body whose approval was withdrawn because of fraud or
willful disregard of public health.
Sec. 900.7 Hearings.
(a) Opportunities to challenge final adverse actions taken by FDA
regarding approval or reapproval of accreditation bodies, withdrawal of
approval of accreditation bodies, or rejection of a proposed fee for
accreditation shall be communicated through notices of opportunity for
informal hearings in accordance with part 16 of this chapter.
(b) A facility that has been denied accreditation is entitled to an
appeals process from the accreditation body. The appeals process shall
be specified in writing by the accreditation body and shall have been
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
(c) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeals
process may appeal to FDA for reconsideration in accordance with
Sec. 900.15.
Secs. 900.8--900.9 [Reserved]
Subpart B--Quality Standards and Certification
Sec. 900.10 Applicability.
The provisions of subpart B are applicable to all facilities under
the regulatory jurisdiction of the United States that provide
mammography services, with the exception of the Department of Veterans
Affairs.
Sec. 900.11 Requirements for certification.
(a) General. After October 1, 1994, a certificate issued by FDA is
required for lawful operation of all mammography facilities subject to
the provisions of this subpart. To obtain a certificate from FDA,
facilities are required to meet the quality standards in Sec. 900.12
and to be accredited by an approved accreditation body or other entity
as designated by FDA.
(b) Application. (1) Certificates. (i) In order to qualify for a
certificate, a facility must apply to an FDA-approved accreditation
body, or to another entity designated by FDA. The facility shall submit
to such body or entity the information required in 42 U.S.C.
263b(d)(1).
(ii) Following the agency's receipt of the accreditation body's
decision to accredit a facility, or an equivalent decision by another
entity designated by FDA, the agency may issue a certificate to the
facility, or renew an existing certificate, if the agency determines
that the facility has satisfied the requirements for certification or
recertification.
(2) Provisional certificates. (i) A new facility beginning
operation after October 1, 1994, is eligible to apply for a provisional
certificate. The provisional certificate will enable the facility to
perform mammography and to obtain
[[Page 60622]]
the clinical images needed to complete the accreditation process. To
apply for and receive a provisional certificate, a facility must meet
the requirements of 42 U.S.C. 263b(c)(2) and submit the necessary
information to an approved accreditation body or other entity
designated by FDA.
(ii) Following the agency's receipt of the accreditation body's
decision that a facility has submitted the required information, FDA
may issue a provisional certificate to a facility upon determination
that the facility has satisfied the requirements of
Sec. 900.11(b)(2)(i). A provisional certificate shall be effective for
up to 6 months from the date of issuance. A provisional certificate
cannot be renewed, but a facility may apply for a 90-day extension of
the provisional certificate.
(3) Extension of provisional certificate. (i) To apply for a 90-
day extension to a provisional certificate, a facility shall submit to
its accreditation body, or other entity designated by FDA, a statement
of what the facility is doing to obtain certification and evidence that
there would be a significant adverse impact on access to mammography in
the geographic area served if such facility did not obtain an
extension.
(ii) The accreditation body shall forward the request, with its
recommendation, to FDA within 2 business days after receipt.
(iii) FDA may issue a 90-day extension for a provisional
certificate upon determination that the extension meets the criteria
set forth in 42 U.S.C. 263b(c)(2).
(iv) There can be no renewal of a provisional certificate beyond
the 90-day extension.
(c) Reinstatement policy. A previously certified facility that has
allowed its certificate to expire, that has been refused a renewal of
its certificate by FDA, or that has had its certificate suspended or
revoked by FDA, may apply to have the certificate reinstated so that
the facility may be considered to be a new facility and thereby be
eligible for a provisional certificate.
(1) Unless prohibited from reinstatement under Sec. 900.11(c)(4), a
facility applying for reinstatement shall:
(i) Contact an FDA-approved accreditation body or other entity
designated by FDA to determine the requirements for reapplication for
accreditation;
(ii) Fully document its history as a previously provisionally
certified or certified mammography facility, including the following
information:
(A) Name and address of the facility under which it was previously
provisionally certified or certified;
(B) Name of previous owner/lessor;
(C) FDA facility identification number assigned to the facility
under its previous certification; and
(D) Expiration date of the most recent FDA provisional certificate
or certificate; and
(iii) Justify application for reinstatement of accreditation by
submitting to the accreditation body or other entity designated by FDA,
a corrective action plan that details how the facility has corrected
deficiencies that contributed to the lapse of, denial of renewal, or
revocation of its certificate.
(2) FDA may issue a provisional certificate to the facility if:
(i) The accreditation body or other entity designated by FDA
notifies the agency that the facility has adequately corrected, or is
in the process of correcting, pertinent deficiencies; and
(ii) FDA determines that the facility has taken sufficient
corrective action since the lapse of, denial of renewal, or revocation
of its previous certificate.
(3) After receiving the provisional certificate, the facility may
lawfully resume performing mammography services while completing the
requirements for certification.
(4) If a facility's certificate was revoked on the basis of an act
described in 41 U.S.C. 263b(i)(1), no person who owned or operated that
facility at the time the act occurred may own or operate a mammography
facility within 2 years of the date of revocation.
Sec. 900.12 Quality standards.
(a) Personnel. The following requirements apply to all personnel
involved in any aspect of mammography, including the production,
processing, and interpretation of mammograms and related quality
assurance activities:
(1) Interpreting physicians. All physicians interpreting mammograms
shall meet the following qualifications:
(i) Initial qualifications. Unless the exemption in paragraph
(a)(1)(iii)(A) of this section applies, before beginning to interpret
mammograms independently, the interpreting physician shall:
(A) Be licensed to practice medicine in a State;
(B)(1) Be certified in an appropriate specialty area by a body
determined by FDA to have procedures and requirements adequate to
ensure that physicians certified by the body are competent to interpret
radiological procedures, including mammography; or
(2) Have had at least 3 months of documented formal training in the
interpretation of mammograms and in topics related to mammography. The
training shall include instruction in radiation physics, including
radiation physics specific to mammography, radiation effects, and
radiation protection. The mammographic interpretation component shall
be under the direct supervision of a physician who meets the
requirements of paragraph (a)(1) of this section;
(C) Have a minimum of 60 hours of documented medical education in
mammography, which shall include: Instruction in the interpretation of
mammograms and education in basic breast anatomy, pathology,
physiology, technical aspects of mammography, and quality assurance and
quality control in mammography. All 60 of these hours shall be category
I and at least 15 of the category I hours shall have been acquired
within the 3 years immediately prior to the date that the physician
qualifies as an interpreting physician. Hours spent in residency
specifically devoted to mammography will be considered as equivalent to
Category I continuing medical education credits and will be accepted if
documented in writing by the appropriate representative of the training
institution; and
(D) Unless the exemption in paragraph (a)(1)(iii)(B) of this
section applies, have interpreted or multi-read at least 240
mammographic examinations within the 6-month period immediately prior
to the date that the physician qualifies as an interpreting physician.
This interpretation or multi-reading shall be under the direct
supervision of an interpreting physician.
(ii) Continuing experience and education. All interpreting
physicians shall maintain their qualifications by meeting the following
requirements:
(A) Following the second anniversary date of the end of the
calendar quarter in which the requirements of paragraph (a)(1)(i) of
this section were completed, the interpreting physician shall have
interpreted or multi-read at least 960 mammographic examinations during
the 24 months immediately preceding the date of the facility's annual
MQSA inspection or the last day of the calendar quarter preceding the
inspection or any date in-between the two. The facility will choose one
of these dates to determine the 24-month period.
(B) Following the third anniversary date of the end of the calendar
quarter in which the requirements of paragraph (a)(1)(i) of this
section were completed,
[[Page 60623]]
the interpreting physician shall have taught or completed at least 15
category I continuing medical education units in mammography during the
36 months immediately preceding the date of the facility's annual MQSA
inspection or the last day of the calendar quarter preceding the
inspection or any date in between the two. The facility will choose one
of these dates to determine the 36-month period. This training shall
include at least six category I continuing medical education credits in
each mammographic modality used by the interpreting physician in his or
her practice; and
(C) Before an interpreting physician may begin independently
interpreting mammograms produced by a new mammographic modality, that
is, a mammographic modality in which the physician has not previously
been trained, the interpreting physician shall have at least 8 hours of
training in the new mammographic modality.
(D) Units earned through teaching a specific course can be counted
only once towards the 15 required by paragraph (a)(1)(ii)(B) of this
section, even if the course is taught multiple times during the
previous 36 months.
(iii) Exemptions. (A) Those physicians who qualified as
interpreting physicians under paragraph (a)(1) of this section of FDA's
interim regulations prior to April 28, 1999, are considered to have met
the initial requirements of paragraph (a)(1)(i) of this section. They
may continue to interpret mammograms provided they continue to meet the
licensure requirement of paragraph (a)(1)(i)(A) of this section and the
continuing experience and education requirements of paragraph
(a)(1)(ii) of this section.
(B) Physicians who have interpreted or multi-read at least 240
mammographic examinations under the direct supervision of an
interpreting physician in any 6-month period during the last 2 years of
a diagnostic radiology residency and who become appropriately board
certified at the first allowable time, as defined by an eligible
certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of
this section.
(iv) Reestablishing qualifications. Interpreting physicians who
fail to maintain the required continuing experience or continuing
education requirements shall reestablish their qualifications before
resuming the independent interpretation of mammograms, as follows:
(A) Interpreting physicians who fail to meet the continuing
experience requirements of paragraph (a)(1)(ii)(A) of this section
shall:
(1) Interpret or multi-read at least 240 mammographic examinations
under the direct supervision of an interpreting physician, or
(2) Interpret or multi-read a sufficient number of mammographic
examinations, under the direct supervision of an interpreting
physician, to bring the physician's total up to 960 examinations for
the prior 24 months, whichever is less.
(3) The interpretations required under paragraph (a)(1)(iv)(A)(1)
or (a)(1)(iv)(A)(2) of this section shall be done within the 6 months
immediately prior to resuming independent interpretation.
(B) Interpreting physicians who fail to meet the continuing
education requirements of paragraph (a)(1)(ii)(B) of this section shall
obtain a sufficient number of additional category I continuing medical
education credits in mammography to bring their total up to the
required 15 credits in the previous 36 months before resuming
independent interpretation.
(2) Radiologic technologists. All mammographic examinations shall
be performed by radiologic technologists who meet the following general
requirements, mammography requirements, and continuing education and
experience requirements:
(i) General requirements. (A) Be licensed to perform general
radiographic procedures in a State; or
(B) Have general certification from one of the bodies determined by
FDA to have procedures and requirements adequate to ensure that
radiologic technologists certified by the body are competent to perform
radiologic examinations; and
(ii) Mammography requirements. Have, prior to April 28, 1999,
qualified as a radiologic technologist under paragraph (a)(2) of this
section or completed at least 40 contact hours of documented training
specific to mammography under the supervision of a qualified
instructor. The hours of documented training shall include, but not
necessarily be limited to:
(A) Training in breast anatomy and physiology, positioning and
compression, quality assurance/quality control techniques, imaging of
patients with breast implants;
(B) The performance of a minimum of 25 examinations under the
direct supervision of an individual qualified under paragraph (a)(2) of
this section; and
(C) At least 8 hours of training in each mammography modality to be
used by the technologist in performing mammography exams; and
(iii) Continuing education requirements. (A) Following the third
anniversary date of the end of the calendar quarter in which the
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section
were completed, the radiologic technologist shall have taught or
completed at least 15 continuing education units in mammography during
the 36 months immediately preceding the date of the facility's annual
MQSA inspection or the last day of the calendar quarter preceding the
inspection or any date in between the two. The facility will choose one
of these dates to determine the 36-month period.
(B) Units earned through teaching a specific course can be counted
only once towards the 15 required in paragraph (a)(2)(iii)(A) of this
section, even if the course is taught multiple times during the
previous 36 months.
(C) At least six of the continuing education units required in
paragraph (a)(2)(iii)(A) of this section shall be related to each
mammographic modality used by the technologist.
(D) Requalification. Radiologic technologists who fail to meet the
continuing education requirements of paragraph (a)(2)(iii)(A) of this
section shall obtain a sufficient number of continuing education units
in mammography to bring their total up to at least 15 in the previous 3
years, at least 6 of which shall be related to each modality used by
the technologist in mammography. The technologist may not resume
performing unsupervised mammography examinations until the continuing
education requirements are completed.
(E) Before a radiologic technologist may begin independently
performing mammographic examinations using a mammographic modality
other than one of those for which the technologist received training
under paragraph (a)(2)(ii)(C) of this section, the technologist shall
have at least 8 hours of continuing education units in the new
modality.
(iv) Continuing experience requirements. (A) Following the second
anniversary date of the end of the calendar quarter in which the
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section
were completed or of October 28, 1997, whichever is later, the
radiologic technologist shall have performed a minimum of 200
mammography examinations during the 24 months immediately preceding the
date of the facility's annual MQSA inspection or the last day of the
calendar quarter or any date in between the two. The facility will
choose one of
[[Page 60624]]
these dates to determine the 24-month period.
(B) Requalification. Radiologic technologists who fail to meet the
continuing experience requirements of paragraph (a)(2)(iv)(A) of this
section shall perform a minimum of 25 mammography examinations under
the direct supervision of a qualified radiologic technologist, before
resuming the performance of unsupervised mammography examinations.
(3) Medical physicists. All medical physicists conducting surveys
of mammography facilities and providing oversight of the facility
quality assurance program under paragraph (e) of this section shall
meet the following:
(i) Initial qualifications. (A) Be State licensed or approved or
have certification in an appropriate specialty area by one of the
bodies determined by FDA to have procedures and requirements to ensure
that medical physicists certified by the body are competent to perform
physics survey; and
(B)(1) Have a masters degree or higher in a physical science from
an accredited institution, with no less than 20 semester hours or
equivalent (e.g., 30 quarter hours) of college undergraduate or
graduate level physics;
(2) Have 20 contact hours of documented specialized training in
conducting surveys of mammography facilities; and
(3) Have the experience of conducting surveys of at least 1
mammography facility and a total of at least 10 mammography units. No
more than one survey of a specific unit within a period of 60 days can
be counted towards the total mammography unit survey requirement. After
April 22, 1999, experience conducting surveys must be acquired under
the direct supervision of a medical physicist who meets all the
requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section;
or
(ii) Alternative initial qualifications. (A) Have qualified as a
medical physicist under paragraph (a)(3) of this section of FDA's
interim regulations and retained that qualification by maintenance of
the active status of any licensure, approval, or certification required
under the interim regulations; and
(B) Prior to the April 22, 1999, have:
(1) A bachelor's degree or higher in a physical science from an
accredited institution with no less than 10 semester hours or
equivalent of college undergraduate or graduate level physics,
(2) Forty contact hours of documented specialized training in
conducting surveys of mammography facilities and,
(3) Have the experience of conducting surveys of at least 1
mammography facility and a total of at least 20 mammography units. No
more than one survey of a specific unit within a period of 60 days can
be counted towards the total mammography unit survey requirement. The
training and experience requirements must be met after fulfilling the
degree requirement.
(iii) Continuing qualifications. (A) Continuing education.
Following the third anniversary date of the end of the calendar quarter
in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this
section were completed, the medical physicist shall have taught or
completed at least 15 continuing education units in mammography during
the 36 months immediately preceding the date of the facility's annual
inspection or the last day of the calendar quarter preceding the
inspection or any date in between the two. The facility shall choose
one of these dates to determine the 36-month period. This continuing
education shall include hours of training appropriate to each
mammographic modality evaluated by the medical physicist during his or
her surveys or oversight of quality assurance programs. Units earned
through teaching a specific course can be counted only once towards the
required 15 units in a 36-month period, even if the course is taught
multiple times during the 36 months.
(B) Continuing experience. Following the second anniversary date of
the end of the calendar quarter in which the requirements of paragraph
(a)(3)(i) or (a)(3)(ii) of this section were completed or of October
28, 1997, whichever is later, the medical physicist shall have surveyed
at least two mammography facilities and a total of at least six
mammography units during the 24 months immediately preceding the date
of the facility's annual MQSA inspection or the last day of the
calendar quarter or any date in-between the two. The facility shall
choose one of these dates to determine the 24-month period. No more
than one survey of a specific facility within a 10-month period on a
specific unit within a period of 60 days can be counted towards the
total mammography unit survey requirement.
(C) Before a medical physicist may begin independently performing
mammographic surveys of a new mammographic modality, that is, a
mammographic modality other than one for which the physicist received
training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this
section, the physicist must receive at least 8 hours of training in
surveying units of the new mammographic modality.
(iv) Reestablishing qualifications. Medical physicists who fail to
maintain the required continuing qualifications of paragraph
(a)(3)(iii) of this section may not perform the MQSA surveys without
the supervision of a qualified medical physicist. Before independently
surveying another facility, medical physicists must reestablish their
qualifications, as follows:
(A) Medical physicists who fail to meet the continuing educational
requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a
sufficient number of continuing education units to bring their total
units up to the required 15 in the previous 3 years.
(B) Medical physicists who fail to meet the continuing experience
requirement of paragraph (a)(3)(iii)(B) of this section shall complete
a sufficient number of surveys under the direct supervision of a
medical physicist who meets the qualifications of paragraphs (a)(3)(i)
and (a)(3)(iii) of this section to bring their total surveys up to the
required two facilities and six units in the previous 24 months. No
more than one survey of a specific unit within a period of 60 days can
be counted towards the total mammography unit survey requirement.
(4) Retention of personnel records. Facilities shall maintain
records to document the qualifications of all personnel who worked at
the facility as interpreting physicians, radiologic technologists, or
medical physicists. These records must be available for review by the
MQSA inspectors. Records of personnel no longer employed by the
facility should not be discarded until the next annual inspection has
been completed and FDA has determined that the facility is in
compliance with the MQSA personnel requirements.
(b) Equipment. Regulations published under Secs. 1020.30, 1020.31,
and 900.12(e) of this chapter that are relevant to equipment
performance should also be consulted for a more complete understanding
of the equipment performance requirements.
(1) Prohibited equipment. Radiographic equipment designed for
general purpose or special nonmammography procedures shall not be used
for mammography. This prohibition includes systems that have been
modified or equipped with special attachments for mammography. This
requirement supersedes the implied acceptance of such systems in
Sec. 1020.31(f)(3) of this chapter.
(2) General. All radiographic equipment used for mammography shall
[[Page 60625]]
be specifically designed for mammography and shall be certified
pursuant to Sec. 1010.2 of this chapter as meeting the applicable
requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at
the date of manufacture.
(3) Motion of tube-image receptor assembly. (i) The assembly shall
be capable of being fixed in any position where it is designed to
operate. Once fixed in any such position, it shall not undergo
unintended motion.
(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of
this section shall not fail in the event of power interruption.
(4) Image receptor sizes. (i) Systems using screen-film image
receptors shall provide, at a minimum, for operation with image
receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.
(ii) Systems using screen-film image receptors shall be equipped
with moving grids matched to all image receptor sizes provided.
(iii) Systems used for magnification procedures shall be capable of
operation with the grid removed from between the source and image
receptor.
(5) Beam limitation and light fields. (i) All systems shall have
beam-limiting devices that allow the useful beam to extend to or beyond
the chest wall edge of the image receptor.
(ii) For any mammography system with a light beam that passes
through the X-ray beam-limiting device, the light shall provide an
average illumination of not less than 160 lux (15 foot candles) at 100
cm or the maximum source-image receptor distance (SID), whichever is
less.
(6) Magnification. (i) Systems used to perform noninterventional
problem solving procedures shall have radiographic magnification
capability available for use by the operator.
(ii) Systems used for magnification procedures shall provide, at a
minimum, at least one magnification value within the range of 1.4 to
2.0.
(7) Focal spot selection. (i) When more than one focal spot is
provided, the system shall indicate, prior to exposure, which focal
spot is selected.
(ii) When more than one target material is provided, the system
shall indicate, prior to exposure, the preselected target material.
(iii) When the target material and/or focal spot is selected by a
system algorithm that is based on the exposure or on a test exposure,
the system shall display, after the exposure, the target material and/
or focal spot actually used during the exposure.
(8) Compression. All mammography systems shall incorporate a
compression device.
(i) Application of compression. Effective October 28, 2002, each
system shall provide:
(A) An initial power-driven compression activated by hands-free
controls operable from both sides of the patient; and
(B) Fine adjustment compression controls operable from both sides
of the patient.
(ii) Compression paddle. (A) Systems shall be equipped with
different sized compression paddles that match the sizes of all full-
field image receptors provided for the system. Compression paddles for
special purposes, including those smaller than the full size of the
image receptor (for ``spot compression'') may be provided. Such
compression paddles for special purposes are not subject to the
requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this
section.
(B) Except as provided in paragraph (b)(8)(ii)(C) of this section,
the compression paddle shall be flat and parallel to the breast support
table and shall not deflect from parallel by more than 1.0 cm at any
point on the surface of the compression paddle when compression is
applied.
(C) Equipment intended by the manufacturer's design to not be flat
and parallel to the breast support table during compression shall meet
the manufacturer's design specifications and maintenance requirements.
(D) The chest wall edge of the compression paddle shall be straight
and parallel to the edge of the image receptor.
(E) The chest wall edge may be bent upward to allow for patient
comfort but shall not appear on the image.
(9) Technique factor selection and display. (i) Manual selection of
milliampere seconds (mA's) or at least one of its component parts
(milliapere (mA) and/or time) shall be available.
(ii) The technique factors (peak tube potential in kilovolt (kV)
and either tube current in mA and exposure time in seconds or the
product of tube current and exposure time in mA's) to be used during an
exposure shall be indicated before the exposure begins, except when
automatic exposure controls (AEC) are used, in which case the technique
factors that are set prior to the exposure shall be indicated.
(iii) Following AEC mode use, the system shall indicate the actual
kilovoltage peak (kVp) and mA's used during the exposure. The mA's may
be displayed as mA and time.
(10) Automatic exposure control. (i) Each screen-film system shall
provide an AEC mode that is operable in all combinations of equipment
configuration provided, e.g., grid, nongrid; magnification,
nonmagnification; and various target-filter combinations.
(ii) The positioning or selection of the detector shall permit
flexibility in the placement of the detector under the target tissue.
(A) The size and available positions of the detector shall be
clearly indicated at the X-ray input surface of the breast compression
paddle.
(B) The selected position of the detector shall be clearly
indicated.
(iii) The system shall provide means for the operator to vary the
selected optical density from the normal (zero) setting.
(11) X-ray film. The facility shall use X-ray film for mammography
that has been designated by the film manufacturer as appropriate for
mammography.
(12) Intensifying screens. The facility shall use intensifying
screens for mammography that have been designated by the screen
manufacturer as appropriate for mammography and shall use film that is
matched to the screen's spectral output as specified by the
manufacturer.
(13) Film processing solutions. For processing mammography films,
the facility shall use chemical solutions that are capable of
developing the films used by the facility in a manner equivalent to the
minimum requirements specified by the film manufacturer.
(14) Lighting. The facility shall make special lights for film
illumination, i.e., hot-lights, capable of producing light levels
greater than that provided by the view box, available to the
interpreting physicians.
(15) Film masking devices. Facilities shall ensure that film
masking devices that can limit the illuminated area to a region equal
to or smaller than the exposed portion of the film are available to all
interpreting physicians interpreting for the facility.
(c) Medical records and mammography reports--(1) Contents and
terminology. Each facility shall prepare a written report of the
results of each mammography examination performed under its
certificate. The mammography report shall include the following
information:
(i) The name of the patient and an additional patient identifier;
(ii) Date of examination;
(iii) The name of the interpreting physician who interpreted the
mammogram;
(iv) Overall final assessment of findings, classified in one of the
following categories:
[[Page 60626]]
(A) ``Negative:'' Nothing to comment upon (if the interpreting
physician is aware of clinical findings or symptoms, despite the
negative assessment, these shall be explained);
(B) ``Benign:'' Also a negative assessment;
(C) ``Probably Benign:'' Finding(s) has a high probability of being
benign;
(D) ``Suspicious:'' Finding(s) without all the characteristic
morphology of breast cancer but indicating a definite probability of
being malignant;
(E) ``Highly suggestive of malignancy:'' Finding(s) has a high
probability of being malignant;
(v) In cases where no final assessment category can be assigned due
to incomplete work-up, ``Incomplete: Need additional imaging
evaluation'' shall be assigned as an assessment and reasons why no
assessment can be made shall be stated by the interpreting physician;
and
(vi) Recommendations made to the health care provider about what
additional actions, if any, should be taken. All clinical questions
raised by the referring health care provider shall be addressed in the
report to the extent possible, even if the assessment is negative or
benign.
(2) Communication of mammography results to the patient. Each
facility shall maintain a system to ensure that the results of each
mammographic examination are communicated to the patient in a timely
manner. If assessments are ``Suspicious'' or ``Highly suggestive of
malignancy'' and the patient has not named a health care provider, the
facility shall make reasonable attempts to ensure that the results are
communicated to the patient as soon as possible.
(i) As soon as possible, but no later than 30 days from the date of
the mammography examination, patients who do not name a health care
provider to receive the mammography report shall be sent the report
described in paragraph (c)(1) of this section, in addition to a written
notification of results in lay terms.
(ii) Each facility that accepts patients who do not have a primary
care provider shall maintain a system for referring such patients to a
health care provider when clinically indicated.
(3) Communication of mammography results to health care providers.
When the patient has a referring health care provider or the patient
has named a health care provider, the facility shall:
(i) Provide a written report of the mammography examination,
including the items listed in paragraph (c)(1) of this section, to that
health care provider as soon as possible, but no later than 30 days
from the date of the mammography examination; and
(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of
malignancy,'' make reasonable attempts to communicate with the health
care provider as soon as possible, or if the health care provider is
unavailable, to a responsible designee of the health care provider.
(4) Recordkeeping. Each facility that performs mammograms: (i)
Shall (except as provided in paragraph (c)(3)(ii) of this section)
maintain mammography films and reports in a permanent medical record of
the patient for a period of not less than 5 years, or not less than 10
years if no additional mammograms of the patient are performed at the
facility, or a longer period if mandated by State or local law; and
(ii) Shall upon request or on behalf of, by the patient,
permanently or temporarily transfer the original mammograms and copies
of the patient's reports to a medical institution, or to a physician or
health care provider of the patient, or to the patient directly;
(iii) Any fee charged to the patients for providing the services in
paragraph (c)(4)(ii) of this section shall not exceed the documented
costs associated with this service.
(5) Mammographic image identification. Each mammographic image
shall have the following information indicated on it in a permanent,
legible, and unambiguous manner and placed so as not to obscure
anatomic structures:
(i) Name of patient and an additional patient identifier.
(ii) Date of examination.
(iii) View and laterality. This information shall be placed on the
image in a position near the axilla. Standardized codes specified by
the accreditation body and approved by FDA in accordance with
Sec. 900.3(b) or Sec. 900.4(a)(8) shall be used to identify view and
laterality.
(iv) Facility name and location. At a minimum, the location shall
include the city, State, and zip code of the facility.
(v) Technologist identification.
(vi) Cassette/screen identification.
(vii) Mammography unit identification, if there is more than one
unit in the facility.
(d) Quality assurance--general. Each facility shall establish and
maintain a quality assurance program to ensure the safety, reliability,
clarity, and accuracy of mammography services performed at the
facility.
(1) Responsible individuals. Responsibility for the quality
assurance program and for each of its elements shall be assigned to
individuals who are qualified for their assignments and who shall be
allowed adequate time to perform these duties.
(i) Lead interpreting physician. The facility shall identify a lead
interpreting physician who shall have the general responsibility of
ensuring that the quality assurance program meets all requirements of
paragraphs (d) through (f) of this section. No other individual shall
be assigned or shall retain responsibility for quality assurance tasks
unless the lead interpreting physician has determined that the
individual's qualifications for, and performance of, the assignment are
adequate.
(ii) Interpreting physicians. All interpreting physicians
interpreting mammograms for the facility shall:
(A) Follow the facility procedures for corrective action when the
images they are asked to interpret are of poor quality, and
(B) Participate in the facility's medical outcomes audit program.
(iii) Medical physicist. Each facility shall have the services of a
medical physicist available to survey mammography equipment and oversee
the equipment-related quality assurance practices of the facility. At a
minimum, the medical physicist(s) shall be responsible for performing
the surveys and mammography equipment evaluations and providing the
facility with the reports described in paragraphs (e)(9) and (e)(10) of
this section.
(iv) Quality control technologist. Responsibility for all
individual tasks within the quality assurance program not assigned to
the lead interpreting physician or the medical physicist shall be
assigned to a quality control technologist(s). The tasks are to be
performed by the quality control technologist or by other personnel
qualified to perform the tasks. When other personnel are utilized for
these tasks, the quality control technologist shall ensure that the
tasks are completed in such a way as to meet the requirements of
paragraph (e) of this section.
(2) Quality assurance records. The lead interpreting physician,
quality control technologist, and medical physicist shall ensure that
records concerning employee qualifications to meet assigned quality
assurance tasks, mammography technique and procedures, quality control
(including monitoring data, problems detected by analysis of that data,
corrective actions, and the effectiveness of the corrective actions),
safety, and protection are properly maintained and updated. These
quality control records shall be
[[Page 60627]]
kept for each test specified in paragraphs (e) and (f) of this section
until the next annual inspection has been completed and FDA has
determined that the facility is in compliance with the quality
assurance requirements or until the test has been performed two
additional times at the required frequency, whichever is longer.
(e) Quality assurance--equipment--(1) Daily quality control tests.
Film processors used to develop mammograms shall be adjusted and
maintained to meet the technical development specifications for the
mammography film in use. A processor performance test shall be
performed on each day that examinations are performed before any
clinical films are processed that day. The test shall include an
assessment of base plus fog density, mid-density, and density
difference, using the mammography film used clinically at the facility.
(i) The base plus fog density shall be within + 0.03 of the
established operating level.
(ii) The mid-density shall be within 0.15 of the
established operating level.
(iii) The density difference shall be within 0.15 of
the established operating level.
(2) Weekly quality control tests. Facilities with screen-film
systems shall perform an image quality evaluation test, using an FDA-
approved phantom, at least weekly.
(i) The optical density of the film at the center of an image of a
standard FDA-accepted phantom shall be at least 1.20 when exposed under
a typical clinical condition.
(ii) The optical density of the film at the center of the phantom
image shall not change by more than 0.20 from the
established operating level.
(iii) The phantom image shall achieve at least the minimum score
established by the accreditation body and accepted by FDA in accordance
with Sec. 900.3(d) or Sec. 900.4(a)(8).
(iv) The density difference between the background of the phantom
and an added test object, used to assess image contrast, shall be
measured and shall not vary by more than 0.05 from the
established operating level.
(3) Quarterly quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
quarterly:
(i) Fixer retention in film. The residual fixer shall be no more
than 5 micrograms per square cm.
(ii) Repeat analysis. If the total repeat or reject rate changes
from the previously determined rate by more than 2.0 percent of the
total films included in the analysis, the reason(s) for the change
shall be determined. Any corrective actions shall be recorded and the
results of these corrective actions shall be assessed.
(4) Semiannual quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
semiannually:
(i) Darkroom fog. The optical density attributable to darkroom fog
shall not exceed 0.05 when a mammography film of the type used in the
facility, which has a mid-density of no less than 1.2 OD, is exposed to
typical darkroom conditions for 2 minutes while such film is placed on
the counter top emulsion side up. If the darkroom has a safelight used
for mammography film, it shall be on during this test.
(ii) Screen-film contact. Testing for screen-film contact shall be
conducted using 40 mesh copper screen. All cassettes used in the
facility for mammography shall be tested.
(iii) Compression device performance. (A) A compression force of at
least 111 newtons (25 pounds) shall be provided.
(B) Effective October 28, 2002, the maximum compression force for
the initial power drive shall be between 111 newtons (25 pounds) and
209 newtons (47 pounds).
(5) Annual quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
annually:
(i) Automatic exposure control performance. (A) The AEC shall be
capable of maintaining film optical density within 0.30 of
the mean optical density when thickness of a homogeneous material is
varied over a range of 2 to 6 cm and the kVp is varied appropriately
for such thicknesses over the kVp range used clinically in the
facility. If this requirement cannot be met, a technique chart shall be
developed showing appropriate techniques (kVp and density control
settings) for different breast thicknesses and compositions that must
be used so that optical densities within 0.30 of the
average under phototimed conditions can be produced.
(B) After October 28, 2002, the AEC shall be capable of maintaining
film optical density (OD) within 0.15 of the mean optical
density when thickness of a homogeneous material is varied over a range
of 2 to 6 cm and the kVp is varied appropriately for such thicknesses
over the kVp range used clinically in the facility.
(C) The optical density of the film in the center of the phantom
image shall not be less than 1.20.
(ii) Kilovoltage peak (kVp) accuracy and reproducibility. (A) The
kVp shall be accurate within 5 percent of the indicated or
selected kVp at:
(1) The lowest clinical kVp that can be measured by a kVp test
device;
(2) The most commonly used clinical kVp;
(3) The highest available clinical kVp, and
(B) At the most commonly used clinical settings of kVp, the
coefficient of variation of reproducibility of the kVp shall be equal
to or less than 0.02.
(iii) Focal spot condition. Until October 28, 2002, focal spot
condition shall be evaluated either by determining system resolution or
by measuring focal spot dimensions. After October 28, 2002, facilities
shall evaluate focal spot condition only by determining the system
resolution.
(A) System Resolution. (1) Each X-ray system used for mammography,
in combination with the mammography screen-film combination used in the
facility, shall provide a minimum resolution of 11 Cycles/millimeters
(mm) (line-pairs/mm) when a high contrast resolution bar test pattern
is oriented with the bars perpendicular to the anode-cathode axis, and
a minimum resolution of 13 line-pairs/mm when the bars are parallel to
that axis.
(2) The bar pattern shall be placed 4.5 cm above the breast support
surface, centered with respect to the chest wall edge of the image
receptor, and with the edge of the pattern within 1 cm of the chest
wall edge of the image receptor.
(3) When more than one target material is provided, the measurement
in paragraph (e)(5)(iii)(A) of this section shall be made using the
appropriate focal spot for each target material.
(4) When more than one SID is provided, the test shall be performed
at SID most commonly used clinically.
(5) Test kVp shall be set at the value used clinically by the
facility for a standard breast and shall be performed in the AEC mode,
if available. If necessary, a suitable absorber may be placed in the
beam to increase exposure times. The screen-film cassette combination
used by the facility shall be used to test for this requirement and
shall be placed in the normal location used for clinical procedures.
(B) Focal spot dimensions. Measured values of the focal spot length
(dimension parallel to the anode cathode axis) and width (dimension
perpendicular to the anode cathode axis) shall be within the tolerance
limits specified in Table 1.
[[Page 60628]]
Table 1
----------------------------------------------------------------------------------------------------------------
Focal Spot Tolerance Limit
-----------------------------------------------------------------------------------------------------------------
Maximum Measured Dimensions
Nominal Focal Spot Size (mm) ---------------------------------------------------------------------------
Width(mm) Length(mm)
----------------------------------------------------------------------------------------------------------------
0.10................................ 0.15 0.15
0.15................................ 0.23 0.23
0.20................................ 0.30 0.30
0.30................................ 0.45 0.65
0.40................................ 0.60 0.85
0.60................................ 0.90 1.30
----------------------------------------------------------------------------------------------------------------
(iv) Beam quality and half-value layer (HVL). The HVL shall meet
the specifications of Sec. 1020.30(m)(1) of this chapter for the
minimum HVL. These values, extrapolated to the mammographic range, are
shown in Table 2. Values not shown in Table 2 may be determined by
linear interpolation or extrapolation.
Table 2
------------------------------------------------------------------------
X-ray Tube Voltage (kilovolt peak) and Minimum HVL
-------------------------------------------------------------------------
Minimum HVL
Designed Operating Range (kV) Measured Operating (millimeters of
Voltage (kV) aluminum)
------------------------------------------------------------------------
Below 50 20 0.20
25 0.25
30 0.30
------------------------------------------------------------------------
(v) Breast entrance air kerma and AEC reproducibility. The
coefficient of variation for both air kerma and mA's shall not exceed
0.05.
(vi) Dosimetry. The average glandular dose delivered during a
single cranio-caudal view of an FDA-accepted phantom simulating a
standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per
exposure. The dose shall be determined with technique factors and
conditions used clinically for a standard breast.
(vii) X-ray field/light field/image receptor/compression paddle
alignment. (A) All systems shall have beam-limiting devices that allow
the useful X-ray beam to extend to or beyond the edges of the image
receptor but by no more than 2 percent of the SID at the chest wall
side.
(B) If a light field that passes through the X-ray beam limitation
device is provided, it shall be aligned with the X-ray field so that
the total of any misalignment of the edges of the light field and the
X-ray field along either the length or the width of the visually
defined field at the plane of the breast support surface shall not
exceed 2 percent of the SID.
(C) The chest wall edge of the compression paddle shall not extend
beyond the chest wall edge of the image receptor by more than one
percent of the SID when tested with the compression paddle placed above
the breast support surface at a distance equivalent to standard breast
thickness. The shadow of the vertical edge of the compression paddle
shall not be visible on the image.
(viii) Uniformity of screen speed. Uniformity of screen speed of
all the cassettes in the facility shall be tested and the difference
between the maximum and minimum optical densities shall not exceed
0.30. Screen artifacts shall also be evaluated during this test.
(ix) System artifacts. System artifacts shall be evaluated with a
high-grade, defect-free sheet of homogeneous material large enough to
cover the mammography cassette and shall be performed for all cassette
sizes used in the facility using a grid appropriate for the cassette
size being tested. System artifacts shall also be evaluated for all
available focal spot sizes and target filter combinations used
clinically.
(x) Radiation output. (A) The system shall be capable of producing
a minimum output of 4.5 mGy air kerma per second (513 milli Roentgen
(mR) per second) when operating at 28 kVp in the standard mammography
(moly/moly) mode at any SID where the system is designed to operate and
when measured by a detector with its center located 4.5 cm above the
breast support surface with the compression paddle in place between the
source and the detector. After October 28, 2002, the system, under the
same measuring conditions shall be capable of producing a minimum
output of 7.0 mGy air kerma per second (800 mR per second) when
operating at 28 kVp in the standard (moly/moly) mammography mode at any
SID where the system is designed to operate.
(B) The system shall be capable of maintaining the required minimum
radiation output averaged over a 3.0 second period.
(xi) Decompression. If the system is equipped with a provision for
automatic decompression after completion of an exposure or interruption
of power to the system, the system shall be tested to confirm that it
provides:
(A) An override capability to allow maintenance of compression;
(B) A continuous display of the override status; and
(C) A manual emergency compression release that can be activated in
the event of power or automatic release failure.
(6) Quality control tests--other modalities. For systems with image
receptor modalities other than screen-film, the quality assurance
program shall be substantially the same as the quality assurance
program recommended by the image receptor manufacturer, except that the
maximum allowable dose shall not exceed the maximum allowable dose for
screen-film systems in paragraph (e)(5)(vi) of this section.
(7) Mobile Units. The facility shall verify that mammography units
used to produce mammograms at more than one location meet the
requirements in paragraphs (e)(1) through (e)(6) of this section. In
addition, at each examination location, before any
[[Page 60629]]
examinations are conducted, the facility shall verify satisfactory
performance of such units using a test method that establishes the
adequacy of the image quality produced by the unit.
(8) Use of test results. (i) After completion of the tests
specified in paragraphs (e)(1) through (e)(7) of this section, the
facility shall compare the test results to the corresponding specified
action limits; or, for nonscreen-film modalities, to the manufacturer's
recommended action limits; or, for post-move, preexamination testing of
mobile units, to the limits established in the test method used by the
facility.
(ii) If the test results fall outside of the action limits, the
source of the problem shall be identified and corrective actions shall
be taken:
(A) Before any further examinations are performed or any films are
processed using the component of the mammography system that failed the
test, if the failed test was that described in paragraphs (e)(1),
(e)(2), (e)(4)(ii), (e)(4)(iii), (e)(5)(i), (e)(5)(iii), (e)(5)(v),
(e)(5)(vi), (e)(6), or (e)(7) of this section;
(B) Within 30 days of the test date for all other tests described
in paragraph (e) of this section.
(9) Surveys. (i) At least once a year, each facility shall undergo
a survey by a medical physicist or by an individual under the direct
supervision of a medical physicist. At a minimum, this survey shall
include the performance of tests to ensure that the facility meets the
quality assurance requirements of the annual tests described in
paragraphs (e)(5) and (e)(6) of this section and the weekly phantom
image quality test described in paragraph (e)(2) of this section.
(ii) The results of all tests conducted by the facility in
accordance with paragraphs (e)(1) through (e)(7) of this section, as
well as written documentation of any corrective actions taken and their
results, shall be evaluated for adequacy by the medical physicist
performing the survey.
(iii) The medical physicist shall prepare a survey report that
includes a summary of this review and recommendations for necessary
improvements.
(iv) The survey report shall be sent to the facility within 30 days
of the date of the survey.
(v) The survey report shall be dated and signed by the medical
physicist performing or supervising the survey. If the survey was
performed entirely or in part by another individual under the direct
supervision of the medical physicist, that individual and the part of
the survey that individual performed shall also be identified in the
survey report.
(10) Mammography equipment evaluations. Additional evaluations of
mammography units or image processors shall be conducted whenever a new
unit or processor is installed, a unit or processor is dissembled and
reassembled at the same or a new location, or major components of a
mammography unit or processor equipment are changed or repaired. These
evaluations shall be used to determine whether the new or changed
equipment meets the requirements of applicable standards in paragraphs
(b) and (e) of this section. All problems shall be corrected before the
new or changed equipment is put into service for examinations or film
processing. The mammography equipment evaluation shall be performed by
a medical physicist or by an individual under the direct supervision of
a medical physicist.
(11) Facility cleanliness. (i) The facility shall establish and
implement adequate protocols for maintaining darkroom, screen, and view
box cleanliness.
(ii) The facility shall document that all cleaning procedures are
performed at the frequencies specified in the protocols.
(12) Calibration of air kerma measuring instruments. Instruments
used by medical physicists in their annual survey to measure the air
kerma or air kerma rate from a mammography unit shall be calibrated at
least once every 2 years and each time the instrument is repaired. The
instrument calibration must be traceable to a national standard and
calibrated with an accuracy of 6 percent (95 percent
confidence level) in the mammography energy range.
(13) Infection control. Facilities shall establish and comply with
a system specifying procedures to be followed by the facility for
cleaning and disinfecting mammography equipment after contact with
blood or other potentially infectious materials. This system shall
specify the methods for documenting facility compliance with the
infection control procedures established and shall:
(i) Comply with all applicable Federal, State, and local
regulations pertaining to infection control; and
(ii) Comply with the manufacturer's recommended procedures for the
cleaning and disinfection of the mammography equipment used in the
facility; or
(iii) If adequate manufacturer's recommendations are not available,
comply with generally accepted guidance on infection control, until
such recommendations become available.
(f) Quality assurance-mammography medical outcomes audit. Each
facility shall establish and maintain a mammography medical outcomes
audit program to followup positive mammographic assessments and to
correlate pathology results with the interpreting physician's findings.
This program shall be designed to ensure the reliability, clarity, and
accuracy of the interpretation of mammograms.
(1) General requirements. Each facility shall establish a system to
collect and review outcome data for all mammograms performed, including
followup on the disposition of all positive mammograms and correlation
of pathology results with the interpreting physician's mammography
report. Analysis of these outcome data shall be made individually and
collectively for all interpreting physicians at the facility. In
addition, any cases of breast cancer among women imaged at the facility
that subsequently become known to the facility shall prompt the
facility to initiate followup on surgical and/or pathology results and
review of the mammograms taken prior to the diagnosis of a malignancy.
(2) Frequency of audit analysis. The facility's first audit
analysis shall be initiated no later than 12 months after the date the
facility becomes certified, or 12 months after April 28, 1999,
whichever date is the latest. This audit analysis shall be completed
within an additional 12 months to permit completion of diagnostic
procedures and data collection. Subsequent audit analyses will be
conducted at least once every 12 months.
(3) Reviewing interpreting physician. Each facility shall designate
at least one interpreting physician to review the medical outcomes
audit data at least once every 12 months. This individual shall record
the dates of the audit period(s) and shall be responsible for analyzing
results based on this audit. This individual shall also be responsible
for documenting the results, notifying other interpreting physicians of
their results and the facility aggregate results. If followup actions
are taken, the reviewing interpreting physician shall also be
responsible for documenting the nature of the followup.
(g) Mammographic procedure and techniques for mammography of
patients with breast implants. (1) Each facility shall have a procedure
to inquire whether or not the patient has breast implants prior to the
actual mammographic exam.
[[Page 60630]]
(2) Except where contraindicated, or unless modified by a
physician's directions, patients with breast implants undergoing
mammography shall have mammographic views to maximize the visualization
of breast tissue.
(h) Consumer complaint mechanism. Each facility shall:
(1) Establish a written and documented system for collecting and
resolving consumer complaints;
(2) Maintain a record of each serious complaint received by the
facility for at least 3 years from the date the complaint was received;
(3) Provide the consumer with adequate directions for filing
serious complaints with the facility's accreditation body if the
facility is unable to resolve a serious complaint to the consumer's
satisfaction;
(4) Report unresolved serious complaints to the accreditation body
in a manner and timeframe specified by the accreditation body.
(i) Clinical image quality. Clinical images produced by any
certified facility must continue to comply with the standards for
clinical image quality established by that facility's accreditation
body.
(j) Additional mammography review and patient notification. (1) If
FDA believes that mammography quality at a facility has been
compromised and may present a serious risk to human health, the
facility shall provide clinical images and other relevant information,
as specified by FDA, for review by the accreditation body or other
entity designated by FDA. This additional mammography review will help
the agency to determine whether the facility is in compliance with this
section and, if not, whether there is a need to notify affected
patients, their physicians, or the public that the reliability,
clarity, and accuracy of interpretation of mammograms has been
compromised.
(2) If FDA determines that any activity related to the provision of
mammography at a facility may present a serious risk to human health
such that patient notification is necessary, the facility shall notify
patients or their designees, their physicians, or the public of action
that may be taken to minimize the effects of the risk. Such
notification shall occur within a timeframe and in a manner specified
by FDA.
Sec. 900.13 Revocation of accreditation and revocation ofaccreditation
body approval.
(a) FDA action following revocation of accreditation. If a
facility's accreditation is revoked by an accreditation body, the
agency may conduct an investigation into the reasons for the
revocation. Following such investigation, the agency may determine that
the facility's certificate shall no longer be in effect or the agency
may take whatever other action or combination of actions will best
protect the public health, including the establishment and
implementation of a corrective plan of action that will permit the
certificate to continue in effect while the facility seeks
reaccreditation. A facility whose certificate is no longer in effect
because it has lost its accreditation may not practice mammography.
(b) Withdrawal of FDA approval of an accreditation body. (1) If FDA
withdraws approval of an accreditation body under Sec. 900.6, the
certificates of facilities previously accredited by such body shall
remain in effect for up to 1 year from the date of the withdrawal of
approval, unless FDA determines, in order to protect human health or
because the accreditation body fraudulently accredited facilities, that
the certificates of some or all of the facilities should be revoked or
suspended or that a shorter time period should be established for the
certificates to remain in effect.
(2) After 1 year from the date of withdrawal of approval of an
accreditation body, or within any shorter period of time established by
the agency, the affected facilities must obtain accreditation from
another accreditation body, or from another entity designated by FDA.
Sec. 900.14 Suspension or revocation of certificates.
(a) Except as provided in paragraph (b) of this section, FDA may
suspend or revoke a certificate if FDA finds, after providing the owner
or operator of the facility with notice and opportunity for an informal
hearing in accordance with part 16 of this chapter, that the owner,
operator, or any employee of the facility:
(1) Has been guilty of misrepresentation in obtaining the
certificate;
(2) Has failed to comply with the standards of Sec. 900.12;
(3) Has failed to comply with reasonable requests of the agency or
the accreditation body for records, information, reports, or materials
that FDA believes are necessary to determine the continued eligibility
of the facility for a certificate or continued compliance with the
standards of Sec. 900.12;
(4) Has refused a reasonable request of a duly designated FDA
inspector, State inspector, or accreditation body representative for
permission to inspect the facility or the operations and pertinent
records of the facility;
(5) Has violated or aided and abetted in the violation of any
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or
(6) Has failed to comply with prior sanctions imposed by the agency
under 42 U.S.C. 263b(h).
(b) FDA may suspend the certificate of a facility before holding a
hearing if FDA makes a finding described in paragraph (a) of this
section and also determines that;
(1) The failure to comply with required standards presents a
serious risk to human health;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the violation or aiding and
abetting of the violation was intentional or associated with fraud.
(c) If FDA suspends a certificate in accordance with paragraph (b)
of this section:
(1) The agency shall provide the facility with an opportunity for
an informal hearing under part 16 of this chapter not later than 60
days from the effective date of this suspension;
(2) The suspension shall remain in effect until the agency
determines that:
(i) Allegations of violations or misconduct were not substantiated;
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The facility's certificate is revoked in accordance with
paragraph (d) of this section;
(d) After providing a hearing in accordance with paragraph (c)(1)
of this section, the agency may revoke the facility's certificate if
the agency determines that the facility:
(1) Is unwilling or unable to correct violations that were the
basis for suspension; or
(2) Has engaged in fraudulent activity to obtain or continue
certification.
Sec. 900.15 Appeals of adverse accreditation or reaccreditation
decisions that preclude certification or recertification.
(a) The appeals procedures described in this section are available
only for adverse accreditation or reaccreditation decisions that
preclude certification or recertification by FDA. Agency decisions to
suspend or revoke certificates that are already in effect will be
handled in accordance with Sec. 900.14.
(b) Upon learning that a facility has failed to become accredited
or reaccredited, FDA will notify the facility that the agency is unable
to certify that facility without proof of accreditation.
(c) A facility that has been denied accreditation or
reaccreditation is
[[Page 60631]]
entitled to an appeals process from the accreditation body, in
accordance with Sec. 900.7. A facility must avail itself of the
accreditation body's appeal process before requesting reconsideration
from FDA.
(d) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeal
process is entitled to further appeal in accordance with procedures set
forth in this section and in regulations published in 42 CFR part 498.
(1) References to the Health Care Financing Administration (HCFA)
in 42 CFR part 498 should be read as the Division of Mammography
Quality and Radiation Programs (DMQRP), Center for Devices and
Radiological Health, Food and Drug Administration.
(2) References to the Appeals Council of the Social Security
Administration in 42 CFR part 498 should be read as references to the
Departmental Appeals Board.
(3) In accordance with the procedures set forth in subpart B of 42
CFR part 498, a facility that has been denied accreditation following
appeal to the accreditation body may request reconsideration of that
adverse decision from DMQRP.
(i) A facility must request reconsideration by DMQRP within 60 days
of the accreditation body's adverse appeals decision, at the following
address: Division of Mammography Quality and Radiation Programs (HFZ-
240), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility
Accreditation Review Committee.
(ii) The request for reconsideration shall include three copies of
the following records:
(A) The accreditation body's original denial of accreditation.
(B) All information the facility submitted to the accreditation
body as part of the appeals process;
(C) A copy of the accreditation body's adverse appeals decision;
and
(D) A statement of the basis for the facility's disagreement with
the accreditation body's decision.
(iii) DMQRP will conduct its reconsideration in accordance with the
procedures set forth in subpart B of 42 CFR part 498.
(4) A facility that is dissatisfied with DMQRP's decision following
reconsideration is entitled to a formal hearing in accordance with
procedures set forth in subpart D of 42 CFR part 498.
(5) Either the facility or FDA may request review of the hearing
officer's decision. Such review will be conducted by the Departmental
Appeals Board in accordance with subpart E of 42 CFR part 498.
(6) A facility cannot perform mammography services while an adverse
accreditation decision is being appealed.
Sec. 900.16 Appeals of denials of certification.
(a) The appeals procedures described in this section are available
only to facilities that are denied certification by FDA after they have
been accredited by an approved accreditation body. Appeals for
facilities that have failed to become accredited are governed by the
procedures set forth in Sec. 900.15.
(b) FDA may deny the application if the agency has reason to
believe that:
(1) The facility will not be operated in accordance with standards
established under Sec. 900.12;
(2) The facility will not permit inspections or provide access to
records or information in a timely fashion; or
(3) The facility has been guilty of misrepresentation in obtaining
the accreditation.
(c)(1) If FDA denies an application for certification by a faciity
that has received accreditation from an approved accreditation body,
FDA shall provide the facility with a statement of the grounds on which
the denial is based.
(2) A facility that has been denied accreditation may request
reconsideration and appeal of FDA's determination in accordance with
the applicable provisions of Sec. 900.15(d).
Sec. 900.17 [Reserved]
Sec. 900.18 Alternative requirements for Sec. 900.12 quality
standards.
(a) Criteria for approval of alternative standards. Upon
application by a qualified party as defined in paragraph (b) of this
section, FDA may approve an alternative to a quality standard under
Sec. 900.12, when the agency determines that:
(1) The proposed alternative standard will be at least as effective
in assuring quality mammography as the standard it proposes to replace,
and
(2) The proposed alternative:
(i) Is too limited in its applicability to justify an amendment to
the standard; or
(ii) Offers an expected benefit to human health that is so great
that the time required for amending the standard would present an
unjustifiable risk to the human health; and
(3) The granting of the alternative is in keeping with the purposes
of 42 U.S.C. 263b.
(b) Applicants for alternatives. (1) Mammography facilities and
accreditation bodies may apply for alternatives to the quality
standards of Sec. 900.12.
(2) Federal agencies and State governments that are not
accreditation bodies may apply for alternatives to the standards of
Sec. 900.12(a).
(3) Manufacturers and assemblers of equipment used for mammography
may apply for alternatives to the standards of Sec. 900.12(b) and (e).
(c) Applications for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Director, Division of Mammography
Quality and Radiation Programs (HFZ-240), Center for Devices and
Radiological Health, Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850. The application for approval of an alternative
standard shall include the following information:
(1) Identification of the original standard for which the
alternative standard is being proposed and an explanation of why the
applicant is proposing the alternative;
(2) A description of the manner in which the alternative is
proposed to deviate from the original standard;
(3) A description, supported by data, of the advantages to be
derived from such deviation;
(4) An explanation, supported by data, of how such a deviation
would ensure equal or greater quality of production, processing, or
interpretation of mammograms than the original standard;
(5) The suggested period of time that the proposed alternative
standard would be in effect; and
(6) Such other information required by the Director to evaluate and
act on the application.
(d) Ruling on applications. (1) FDA may approve or deny, in whole
or in part, a request for approval of an alternative standard or any
amendment or extension thereof, and shall inform the applicant in
writing of this action. The written notice shall state the manner in
which the requested alternative standard differs from the agency
standard and a summary of the reasons for approval or denial of the
request. If the request is approved, the written notice shall also
include the effective date and the termination date of the approval and
a summary of the limitations and conditions attached to the approval
and any other information that may be relevant to the approved request.
Each approved alternative standard shall be assigned an identifying
number.
[[Page 60632]]
(2) Notice of an approved request for an alternative standard or
any amendment or extension thereof shall be placed in the public docket
file in the Dockets Management Branch and may also be in the form of a
notice published in the Federal Register. The notice shall state the
name of the applicant, a description of the published agency standard,
and a description of the approved alternative standard, including
limitations and conditions attached to the approval of the alternative
standard.
(3) Summaries of the approval of alternative standards, including
information on their nature and number, shall be provided to the
National Mammography Quality Assurance Advisory Committee.
(4) All applications for approval of alternative standards and for
amendments and extensions thereof and all correspondence (including
written notices of approval) on these applications shall be available
for public disclosure in the Dockets Management Branch, excluding
patient identifiers and confidential commercial information.
(e) Amendment or extension of an alternative standard. An
application for amending or extending approval of an alternative
standard shall include the following information:
(1) The approval number and the expiration date of the alternative
standard;
(2) The amendment or extension requested and the basis for the
amendment or extension; and
(3) An explanation, supported by data, of how such an amendment or
extension would ensure equal or greater quality of production,
processing, or interpretation of mammograms than the original standard.
(f) Applicability of the alternative standards. (1) Except as
provided in paragraphs (f)(2) and (f)(3) of this section, any approval
of an alternative standard, amendment, or extension may be implemented
only by the entity to which it was granted and under the terms under
which it was granted. Other entities interested in similar or identical
approvals must file their own application following the procedures of
paragraph (c) of this section.
(2) When an alternative standard is approved for a manufacturer of
equipment, any facility using that equipment will also be covered by
the alternative standard.
(3) The agency may extend the alternative standard to other
entities when FDA determines that expansion of the approval of the
alternative standard would be an effective means of promoting the
acceptance of measures to improve the quality of mammography. All such
determinations will be publicized by appropriate means.
(g) Withdrawal of approval of alternative requirements. FDA shall
amend or withdraw approval of an alternative standard whenever the
agency determines that this action is necessary to protect the human
health or otherwise is justified by Sec. 900.12. Such action will
become effective on the date specified in the written notice of the
action sent to the applicant, except that it will become effective
immediately upon notification of the applicant when FDA determines that
such action is necessary to prevent an imminent health hazard.
Dated: November 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29596 Filed 11-6-97; 1:07 pm]
BILLING CODE 4160-01-F
