[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Proposed Rules]
[Pages 65235-65237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32462]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1020
[Docket No. 97N-0427]
RIN 0910-ZA06
Diagnostic X-Ray Equipment Performance Standard; Request for
Comments and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to propose amendments to the performance standard for
diagnostic x-ray systems and their major components. The agency is
taking this action to address changes in the technology and use of
radiographic and fluoroscopic systems. The agency is issuing this
advance notice of proposed rulemaking (ANPRM) in accordance with its
policy of early public disclosure of rulemaking activities. The FDA is
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soliciting comments and information from interested persons concerning
the subject matter of the proposed amendments.
DATES: Submit written comments on the proposed amendments by March 11,
1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION section for
electronic access to the summary of concepts for amendments and a
summary of the April 8 through 9, 1997, meeting of the Technical
Electronic Product Radiation Safety Standards Committee (TEPRSSC).
Submit written requests for single copies of the Diagnostic X-Ray
Equipment Performance Standard to the Division of Small Manufacturers
Assistance (DSMA), Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send two self-addressed adhesive labels to assist that office in
processing your request or fax your request to 301-443-8818.
FOR FURTHER INFORMATION CONTACT: Thomas B. Shope, Center for Devices
and Radiological Health (HFZ-140), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3314, ext. 32.
SUPPLEMENTARY INFORMATION:
I. Background
FDA, under authority conferred by the Public Health Service Act as
amended by the Radiation Control for Health and Safety Act (RCHSA) of
1968 (Pub. L. 90-602 (21 U.S.C. 360hh-360ss)), administers an
electronic product radiation control program to protect the public
health and safety. This authority provides for the development and
administration of radiation safety performance standards for electronic
products.
In order for mandatory performance standards to achieve intended
public health protection, attention must be given to keeping the
requirements of standards updated and appropriate. A number of
technological developments have been or will be implemented for
radiographic and fluoroscopic x-ray systems that are not addressed by
the performance standard or that present problems in the application of
the requirements of the current standard. FDA is developing proposed
amendments to the performance standard for radiographic and
fluoroscopic systems that take into account new technology, clarify
certain provisions, and address additional requirements that may be
determined to be necessary to provide for adequate radiation safety of
these systems.
On October 16 and 17, 1992, the American College of Radiology and
FDA sponsored a workshop on fluoroscopy to develop strategies for
improvement in performance, safety and control of fluoroscopic
equipment. Physicians, physicists, State and Federal government
regulators, and fluoroscopic equipment manufacturers attended the
workshop. They discussed and made recommendations for different ways to
approach fluoroscopic radiation safety issues and concerns, including
regulatory solutions.
In the Federal Register of May 19, 1994 (59 FR 26402), FDA
published a final rule effective May 19, 1995, amending performance
requirements for fluoroscopic systems to address the immediate concern
of preventing unlimited exposure rates during the high-level control
mode of fluoroscopic system operation. The TEPRSSC discussed the status
of standards for fluoroscopic systems and new clinical uses during a
meeting held on April 9 through 10, 1996. TEPRSSC is a permanent
statutory advisory committee established by statute that FDA must
consult prior to issuing standards under the RCHSA.
At a meeting of the TEPRSSC held on April 8 through 9, 1997, FDA
presented general concepts for amendments to the performance standard
for radiographic and fluoroscopic systems.
The committee recommended that FDA pursue development of the
amendments in the areas discussed in section II of this notice.
A transcript of the TEPRSSC April 8 through 9, 1997, meeting may be
ordered from Miller Reporting Co., Inc., 507 C St. NE., Washington, DC
20002, 202-546-6666 or FAX 202-546-1502.
Individuals or organizations wishing to receive copies of draft
amendments or related documents distributed for review during the
development of these amendments may have their names placed on the
mailing list by writing to: Office of Science and Technology (HFZ-140),
Center for Devices and Radiological Health, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-443-
9101, e-mail: [email protected]
II. Concepts for Amendments to the Standard
FDA has identified the following nine areas as candidates for
amendments to accommodate changes in technology and clinical use of
radiographic and fluoroscopic systems. The discussion below each
concept is not intended to indicate the specific content of the
proposed amendment to be developed, but is meant only to describe the
need and FDA's proposed approach. The specific regulatory changes or
proposed standards will be included in a future proposed rule. Comments
received in response to this notice will be used to develop the
proposed amendments. FDA requests comments on the following conceptual
changes:
1. Conversion to the International System of Units (SI) quantities
and units for the entire standard. This proposal is to amend all
sections of the performance standard for diagnostic x-ray systems to
use the radiation quantity ``air kerma'' in place of the quantity
``exposure'' and to change the units to the SI.
2. Clarification of applicability of requirements to technological
developments, such as digital imaging, digital recording and solid-
state x-ray imagers. The current organization and structure of the
standard assumes the presence of an x-ray image intensifier as the
basis for many of the requirements for fluoroscopic systems. This
assumption may be inappropriate for digital fluoroscopy systems that
may use new types of digital image receptors. Such systems may not have
an image intensifier tube. The structure of the radiographic section of
the standard is based on radiographic film as the image receptor and
revisions are needed to incorporate technological developments in that
area. It would be desirable to the extent possible to use terminology
consistent with usage adopted by the International Electrotechnical
Commission (IEC).
3. Amendment to incorporate draft Compliance Policy Guide on
Information to be Provided to Users (21 CFR 1020.30(h)). This proposal
would amend the requirements on the content of information that must be
provided to users to include specific information on the air kerma rate
for certain fluoroscopic modes of operation. This amendment would
incorporate into the standard a draft Compliance Policy Guide that has
been developed, but not yet issued, and is intended to interpret
Sec. 1020.30(h) for certain ``unique'' modes of fluoroscopic system
operation.
4. Amendment to add requirements for minimum half-value layer (HVL)
for systems designed for interventional radiology (Sec. 1020.30(m)).
This proposal would increase the minimum half-value layer requirements
for fluoroscopic systems designed for interventional radiology. Such a
requirement will require definition of a ``fluoroscopic system designed
for interventional
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fluoroscopy.'' As a concept for discussion, fluoroscopic systems
designed for interventional radiology might be defined as systems that
permit the beam axis to be positioned at an angle relative to the
normal to the table top. Systems in which the x-ray beam direction is
fixed with respect to the plane of the tabletop, such as conventional
radiographic/ fluoroscopic systems, would not be included in this
definition.
5. Amendment to require improved x-ray field limitation (21 CFR
1020.32(b)(2)(v)). This proposal would require improved limitation of
the x-ray field for fluoroscopic equipment to match the actual area of
the image receptor being used for image capture, thereby reducing the
amount of non-useful beam striking the patient.
6. Amendment to clarify the requirements for the minimum source-
skin distance for small, mobile, or portable mini C-arm systems
(Sec. 1020.32(g)). This amendment would address numerous requested and
granted variances for fluoroscopic systems that have limited source-
image receptor distances. The amendment would specify the conditions
under which a shorter-than-standard source-skin distance is permitted
and would obviate the need for continued variances from the standard.
7. Amendment to require indication of cumulative exposure time on
fluoroscopic systems (Sec. 1020.32(h)). The proposed amendment would
require the means to indicate the cumulative time of fluoroscopic
irradiation of a patient during an examination or procedure.
8. Amendment to require provision of ``last-image-hold'' feature on
fluoroscopic systems (Sec. 1020.32(j)). This amendment would require
that all fluoroscopic x-ray systems be provided with a means to
continuously display the last image acquired following termination of
any exposure period.
9. Amendment to require indication of air kerma rate and cumulative
air kerma on fluoroscopic systems (Sec. 1020.32(k)). The proposed
amendment would require the means to display to the fluoroscopist at
the fluoroscopist's working position the cumulative air kerma and the
air kerma rate (air kerma per unit time) at which air kerma accrues
during irradiation of a patient in an examination or procedure.
III. Electronic Access
The summary of concepts for amendments entitled ``Concepts for
Proposed Amendments to the Performance Standard for Diagnostic X-ray
Systems, August 1, 1997,'' may be accessed at the CDRH Home Page on the
World Wide Web. It is available on the Topic Index page at: http://
www.fda.gov/cdrh/topindx under ``Fluoroscopy''. A text-only version of
the CDRH site is also available from a computer or VT-100 compatible
terminal by dialing 800-222-0185 (terminal settings are 8/1/N). Once
the modem answers, press Enter several times and then select menu
choice 1: FDA BULLETIN BOARD SERVICE. From there, follow instructions
for logging in, and at the BBS TOPICS PAGE, arrow down to the FDA Home
Page (do not select the first CDRH entry). Then select Medical Devices
and Radiological Health. From there, select CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH for general information, or arrow down for specific
topics.
The document may also be obtained by fax by calling the CDRH Facts-
On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. At the first voice prompt press 1 to access DSMA Facts,
at the second voice prompt press 2, and then enter the document number
591 followed by the pound sign (#). Then follow the remaining voice
prompts to complete your request.
A summary of the TEPRSSC April 8 through 9, 1997, meeting is
available on the CDRH Home Page at the same address given above for the
concepts for amendments document.
IV. Comments
Interested persons may, on or before March 11, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposed amendment. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Interested persons also are invited to participate in the
development of proposed amendments by submitting written data, views,
or arguments concerning the subject matter of the amendments, or
related topics suggested for inclusion in the amendments. In addition
to general comments and recommendations, respondents are encouraged to
include suggested text for provisions of the proposed amendments that
reflect their recommended performance requirements. A statement of
rationale should accompany any such proposed text. When a determination
is made on the content of the proposed amendments, they will be
published as notices of proposed rulemaking with opportunity given for
public comment. Information and comments are specifically invited on
the following topics:
1. For concepts 4 through 9 in section II of this document,
recommendation for whether the amendments should be limited only to
equipment designed for interventional procedures or for all
fluoroscopic systems. If only for interventional systems, how should
``interventional fluoroscopic systems'' be defined?
2. The desirability and technical feasibility of amendments of the
type described in section II of this document.
3. Recommended performance requirements to be included in the
proposed amendments, including attendant methods and conditions of
measurement.
4. Suggestions and supporting data for other amendments to the
performance standard for radiographic or fluoroscopic equipment,
including moving towards more outcome-based performance standards,
which may be needed to provide for adequate radiation safety.
5. The possible environmental impact of this action, including
factors such as radiation exposure reduction or prevention and economic
consequences in relation to expected benefits (cost-benefit
relationship), and the anticipated costs of providing such features or
meeting the requirements.
6. Any additional terms or definitions that are needed to better
specify the intent or meaning of the regulations as they apply to the
equipment.
This ANPRM is issued under 21 U.S.C. 321 and under the authority of
the Commissioner of Food and Drugs.
Dated: October 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32462 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F
