[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6691]
[[Page Unknown]]
[Federal Register: March 23, 1994]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 806
Medical Devices; Reports of Corrections and Removals; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 806
[Docket No. 91N-0396]
Medical Devices; Reports of Corrections and Removals
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
that manufacturers, importers, and distributors report promptly to FDA
any corrections or removals of a device undertaken to reduce a risk to
health posed by the device or to remedy a violation of the Federal
Food, Drug, and Cosmetic Act (the act) caused by the device which may
present a risk to health. Manufacturers, distributors, and importers
would not have to report actions taken to improve the performance or
quality of a device which are not intended to reduce a risk to health
posed by the device or remedy a violation of the act caused by the
device. Nor would manufacturers, distributors, and importers have to
report actions defined as routine servicing. FDA believes that the
proposed reporting requirements are necessary to protect the public
health by assuring that the agency has current and complete information
regarding those actions taken to eliminate risk to health caused by
devices. Reports of such actions will improve the agency's ability to
evaluate device-related problems and to take prompt action against
potentially dangerous devices.
FDA is directed to implement this new authority by regulation under
certain provisions of the Safe Medical Devices Act of 1990 (the SMDA).
DATES: Written comments by June 21, 1994. The agency proposes that any
final rule that may issue based on this proposal become effective 30
days after the date of publication of the final rule.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
John H. Samalik, Center for Devices and Radiological Health (HFZ-
300), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-4595.
SUPPLEMENTARY INFORMATION:
I. Statutory Authority and Legislative History
The current regulatory framework for medical devices is the result
of four statutes: (1) The act (21 U.S.C. 321-394), (2) the Medical
Device Amendments of 1976 (Pub. L. 94-295) (the 1976 amendments), (3)
the SMDA (Pub. L. 101-629), and (4) the Medical Device Amendments of
1992 (Pub. L. 102-300) (the 1992 amendments).
The act prohibited the marketing of adulterated or misbranded
devices. The 1976 amendments amended the act with new authority
expressly designed to ensure the safety and effectiveness of medical
devices.
The 1976 amendments gave FDA, for the first time, premarket
controls over medical devices (e.g., classification, premarket
notification, and premarket approval). Additionally, the 1976
amendments strengthened the act's postmarket controls relating to
medical devices, giving FDA the authority to require patient
notification; repair, replacement, or refund; reporting and
recordkeeping; current good manufacturing practices (CGMP's); and
restrictions on the distribution of certain devices.
The SMDA, by streamlining in some places and augmenting authority
in others, refines the premarket and postmarket controls relating to
medical devices added to the act by the 1976 amendments. Among the
provisions of the SMDA that augment postmarket controls is the reports
and records of corrections and removals requirement of section 519(f)
of the act (21 U.S.C. 360i(f)).
Section 519(f) of the act directs FDA to promulgate regulations
requiring reporting and recordkeeping of correction and removal actions
taken by device manufacturers, distributors, and importers. Under
section 519(f)(1) of the act, device manufacturers, distributors, and
importers are to report promptly to FDA any correction or removal of a
device undertaken: (1) To reduce a risk to health posed by the device;
or (2) to remedy a violation of the act caused by a device which may
present a risk to health. Section 519(f)(1) of the act also requires
manufacturers, distributors, and importers to keep records of those
corrections and removals that are not required to be reported to FDA.
Section 519(f)(2) of the act provides that no report of a correction or
removal action under section 519(f)(1) of the act may be required if a
report of the correction or removal action is required and has been
submitted to FDA under section 519(a) of the act. Section 519(f)(3) of
the act states that the terms ``correction'' and ``removal'' do not
include routine servicing.
Section 519(f) of the act was enacted because Congress was
concerned that device manufacturers, distributors, and importers were
carrying out product corrections or removals without notifying FDA, or
not notifying the agency in a timely fashion. (H. Rept. 808, 101st
Cong., 2d sess. 29 (1990); S. Rept. 513, 101st Cong., 2d sess. 23
(1990)). Industry's failure to report corrections and removals,
particularly those undertaken to reduce risks associated with the use
of a device, Congress explained, ``denies the agency the opportunity to
fulfill its public health responsibilities by evaluating device-related
problems and the adequacy of corrective actions,'' (S. Rept. 513, 101st
Cong., 2d sess. 23 (1990)), and ``has seriously interfered with the
FDA's ability to take prompt action against potentially dangerous
devices,'' (H. Rept. 808, 101st Cong., 2d sess. 29 (1990)).
At the same time, Congress did not want to overburden industry or
FDA with overreporting requirements. The reporting requirements thus
apply only to the ``more important postmarket actions, excluding those
events already reported to the [agency].'' However, to ensure that FDA
has access to all relevant information on corrections or removals, for
those corrections and removals that need not be reported, Congress
provided that records be maintained. (S. Rept. 513, 101st Cong., 2d
sess. 23 (1990)).
Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to
promulgate substantive binding regulations for the efficient
enforcement of the act. Weinberger v. Hynson, Westcott & Dunning, Inc.,
412 U.S. 609 (1973); see also Weinberger v. Bentex Pharmaceuticals,
Inc., 412 U.S. 645, 653 (1973); National Ass'n of Pharmaceutical
Manufacturers v. FDA, 637 F.2d 877 (2d Cir. 1981); National
Confectioners Ass'n v. Califano, 569 F.2d 690 (D.C. Cir. 1978);
National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir.),
cert. denied, 423 U.S. 827 (1975).
Section 704(a) of the act (21 U.S.C. 374(a)) provides that for
purposes of enforcement of the act, any duly designated FDA employee is
authorized, among other things: (1) To enter, at reasonable times, any
factory, warehouse, or establishment in which devices are manufactured,
processed, packed, or held, or to enter any vehicle being used to
transport or hold devices, and (2) to inspect, at reasonable times and
within reasonable limits and in a reasonable manner, such factory,
warehouse, establishments, or containers, and labeling therein. Section
704(e) of the act requires that any person required under section 519
of the act to maintain records and every person who is in charge or
custody of such records must, upon request of an officer or employee
designated by FDA, permit such officer or employee at all reasonable
times to have access to, and copy and verify, such record.
II. Scope of the Proposed Regulations
The proposed regulations implementing the provisions of section
519(f) of the act will be set out in new 21 CFR part 806. Proposed
Sec. 806.1(a) provides generally that device manufacturers,
distributors, and importers are required to report promptly to FDA
certain actions concerning device corrections and removals, and to
maintain records of all corrections and removals regardless of whether
such corrections and removals are required to be reported to FDA.
Proposed Sec. 806.1(b) describes the actions that are not subject
to the reporting and recordkeeping requirements of the regulation (set
out at proposed Sec. 806.10). Those actions are:
1. Actions undertaken by device manufacturers, distributors, and
importers to improve the performance or quality of a device which are
not intended to reduce a risk to health posed by the device or remedy a
violation of the act caused by the device.
2. Routine servicing as defined in proposed Sec. 806.2(i).
3. Actions similar to item 1, undertaken by manufacturers of
general purpose articles, such as chemical reagents or laboratory
equipment, whose uses are generally known by persons trained in their
use and which are not labeled or promoted or otherwise intended for
medical uses.
III. Reports of Corrections and Removals
A. Who Must Report and When
Proposed Sec. 806.10(a) requires device manufacturers,
distributors, and importers to submit a written report to FDA of any
correction or removal of a device undertaken: (1) To reduce a risk to
health posed by the device; or (2) to remedy a violation of the act
caused by the device which may present a risk to health. Only one
report is required for each reportable event. The person initiating the
action to correct or remove a device is required to report. In the case
of a foreign manufacturer or distributor, the U.S. designated agent is
required to report. If the distributor or importer corrects or removes
a product on its own, then the distributor or importer is required to
report the action. Regardless of who submits the report or to which FDA
district office the report is submitted, the name and location of the
manufacturer must be reported.
B. Time and Place for Submission of Reports
Under proposed Sec. 806.10(b), device manufacturers, distributors,
and importers must submit required correction or removal reports within
10 calendar days of initiating a device correction or removal to the
appropriate FDA district office listed in Sec. 5.115 (21 CFR 5.115) for
their location and region. If the device is manufactured at multiple
manufacturing sites, the report must be submitted to the FDA district
office where the device is finally assembled and/or packaged. A foreign
manufacturer or distributor that ships devices to the United States
shall submit its own reports of corrective or removal actions through
the U.S. designated agent on its behalf. The U.S. designated agent
shall submit such reports to the FDA district office in which the
agent's office is located.
C. What to Report
Under proposed Sec. 806.10(c), device manufacturers, distributors,
and importers must include the following information in the report:
1. The name, address, and telephone number of the manufacturer or
distributor, (including foreign manufacturer), and the name, title,
address, and telephone number of the individual responsible for
conducting the device correction or removal.
2. The brand name, common or usual name, classification name and
product name if known, and the intended use of the device.
3. Marketing status of the device, i.e., any applicable premarket
notification number, premarket approval number, or indicate if a
preamendments device, and the device listing number. (A manufacturer or
distributor that does not have an FDA establishment registration number
must indicate in the report whether it has ever registered with FDA).
4. The correction or removal report number.
5. The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
6. The manufacturer's name, address, telephone number, and contact
person if different from that of the person submitting the report.
7. A complete description of the event(s) giving rise to the
information reported and the corrective or removal actions that have
been, and are expected to be taken.
8. Any illnesses or injuries that have occurred with use of the
device. If applicable, include the medical device report numbers.
9. The total number of devices manufactured or distributed and the
number in the same batch, lot, or equivalent unit of production subject
to the correction or removal.
10. The date of manufacture or distribution and the device's
expiration date if applicable.
11. The names, addresses, and telephone numbers of all domestic and
foreign consignees of the device and the dates and number of devices
distributed to each such consignee.
12. A copy of all communications regarding the correction or
removal, and the names and addresses of all recipients of the
communications if the number of recipients of the communications is
different than number 11 above.
The agency is using the opportunity under this proposed rule to
solicit comments regarding whether it would be desirable to develop a
form to collect reports of removal and correction data. Interested
persons should submit written comments to the Dockets Management Branch
(address above). FDA will consider any comments received and will
address the development and use of a form to collect reports of
correction and removal data in any final rule that is published.
D. FDA Review of Reports
FDA will review any correction or removal report submitted under
proposed Sec. 806.10 and where the correction or removal involves:
1. Some, but not all, of the devices of a particular lot, model,
code, etc., FDA will determine whether the action should be extended to
other units of the same device, other products of the same manufacturer
or distributor, or to similar products of other manufacturers or
distributors.
2. All of the devices of a particular lot, model, code, etc., FDA
will classify the action as either one of the following: (a) Recall, if
the action was undertaken to remedy a violation of the act caused by
the device which may present a risk to health; or (b) safety alert, if
the action was undertaken to reduce a risk to health posed by the
device and not to remedy a violation of the act caused by the device.
IV. Records of Corrections and Removals Not Required To Be Reported
Proposed Sec. 806.20(a) would require manufacturers, distributors,
and importers who undertake a correction or removal of a device that is
not required to be reported to FDA under proposed Sec. 806.10 to keep a
record of such correction or removal.
Under proposed Sec. 806.20(b), records of corrections and removals
not required to be reported to FDA under proposed Sec. 806.10 must
contain the following information:
1. The brand name, common or usual name, classification name and
product code if known, and the intended use of the device.
2. The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
3. A complete description of the event giving rise to the
information reported and the corrective or removal action that has
been, and is expected to be, taken.
4. Justification for not reporting the correction or removal action
to FDA shall contain conclusions, any followups, and be reviewed and
evaluated by a designated person.
5. A copy of all communications regarding the correction or
removal.
Under proposed Sec. 806.20(c), manufacturers, distributors, and
importers must retain all records required under proposed Sec. 806.20
for a period of 2 years beyond the expected life of the device, even if
the manufacturer or distributor has ceased to manufacture or distribute
the device. Records required to be maintained under Sec. 806.20(c) must
be transferred to the new owner of the device and maintained for the
required period of time.
V. FDA Access to Records and Reports
Under proposed Sec. 806.30, manufacturers, distributors, and
importers required to maintain records concerning corrections or
removals and every person who is in charge or custody of such records
must, upon request of an officer or employee designated by FDA and
pursuant to section 704(e) of the act, permit such officer or employee
at all reasonable times to have access to, and to copy and verify, such
records and reports.
VI. Public Availability of Reports
Proposed Sec. 806.40 makes clear that any device correction or
removal report submitted to FDA is available for public disclosure in
accordance with the agency's public information regulations at part 20
(21 CFR part 20).
Before public disclosure of a report, FDA will delete the following
from the report in accordance with part 20: (1) Any information that
constitutes trade secret or confidential commercial or financial
information under Sec. 20.61; and (2) any personnel, medical, and
similar information, including the serial numbers of implanted devices,
which would constitute a clearly unwarranted invasion of personal
privacy under Sec. 20.63; provided, that except for the information
under Sec. 20.61, FDA will disclose to a patient who requests a report
all the information in the report concerning that patient.
VII. Enforcement
Section 301 of the act (21 U.S.C. 331) sets forth prohibited acts.
Persons who violate section 301 of the act may be restrained, under
section 302 of the act (21 U.S.C. 332), or may be imprisoned or fined
under section 303 of the act (21 U.S.C. 333).
Violations of any final rule based on this proposed rule, which is
issued under the authority of sections 502, 510, 519, 520, 701, and 704
of the act (21 U.S.C. 352, 360, 360i, 360j, 371, and 374), will result
in committing one or more of the following violations of section 301 of
the act:
1. Section 301(e) of the act, which prohibits, among other things,
the failure to establish or maintain any record, or make any report,
required under section 519 of the act or the refusal to permit officers
or employees designated by FDA to have access to or verification or
copying of any such required record.
2. Section 301(f) of the act prohibits the refusal to permit entry
or inspection as authorized by section 704 of the act. Section 704(e)
of the act requires every person required under section 519 of the act
to maintain records and every person who is in charge or custody of
such records, upon request of an officer or employee designated by FDA,
to permit such officer or employee to have access to, and copy and
verify, such records.
3. Section 301(q) of the act prohibits, among other things, the
failure or refusal to furnish any material or information required by
or under section 519 of the act.
In addition, section 502(t)(2) of the act deems a device to be
misbranded if there is a failure or refusal to furnish any material or
information required by or under section 519 of the act respecting the
device. Sections 301 (a), (b), (c), (g), and (k) of the act prohibit
several actions with respect to interstate commerce in misbranded
devices. FDA may also seize misbranded devices under section 304 of the
act (21 U.S.C. 334) as well as restrain or prosecute violations of
section 301 of the act relating to misbranded devices.
In addition to the criminal and civil enforcement mechanisms
described above, the SMDA added section 303(f) to the act, which
provides for the first time that any person who fails to demonstrate
substantial compliance with section 519(f) of the act may be subject to
civil penalties. These penalties do not apply to any person who commits
minor violations of section 519(f) (only with respect to correction
reports) if such person demonstrates substantial compliance with
section 519(f). A civil penalty may not exceed $15,000 for a single
violation, and may not exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
VIII. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IX. Economic Impact
FDA has carefully examined the costs and benefits of this proposed
rule in accordance with the requirements of Executive Order 12866 and
the Regulatory Flexibility Act (Pub. L. 96-354). The agency concludes
that this proposed rule is not a significant regulatory action as
defined in Executive Order 12866. Further, the agency certifies that
the proposed rule, if implemented, will not have a significant impact
on a substantial number of small entities, as defined in the Regulatory
Flexibility Act. The agency estimates that it will receive no more than
800 reports per year from device manufacturers regarding removals and
corrections. For the estimated 800 reports the total cost would be
$240,000. In addition, the agency expects that there will be other
instances of corrections and removals that will not have to be reported
to the agency, but will have to be maintained in files at the
manufacturer's site. These records are to be made available to FDA
inspectors upon request. The cost of preparing these records would be
$120,000 per year. An assessment of the economic impact of any final
rule based on this proposal has been placed on file in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
X. Paperwork Reduction Act
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 35). The title,
description, and respondent description of the information collection
are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: ``Reports of Corrections and Removals'' for manufacturers,
importers, and distributors of medical devices under Public Law 101-
629--General Requirements.
Description: FDA is proposing to implement provisions of the SMDA
that require a manufacturer, importer, or distributor of a device to
report promptly to FDA any correction or removal of a device undertaken
by a manufacturer, importer, or distributor of a device if the
correction or removal was undertaken to reduce a risk to health posed
by the device or to remedy a violation of the act caused by the device
which may present a risk to health. The purpose of the proposed changes
is to improve the protection of the public health by assuring that FDA
has current and complete information regarding those actions taken to
eliminate any risk to health caused by the device.
Estimated Annual Reporting Burden
Section 806.10:
Annual Number of Responses.................................... 800
Average Burden per Response (hours)........................... 10
Total Annual Burden (hours)................................... 8,000
Section 806.20:
Annual Number of Responses.................................... 400
Average Burden per Response (hours)........................... 10
Total Annual Burden (hours)................................... 4,000
As required by section 3504(h) of the Paperwork Reduction Act of
1980, FDA has submitted a copy of this proposed rule to OMB for its
review of these information collection requirements. Other
organizations and individuals desiring to submit comments regarding
this burden estimate or any aspects of these information collection
requirements, including suggestions for reducing the burden, should
direct them to FDA's Dockets Management Branch (address above) and to
the Office of Information and Regulatory Affairs, OMB, rm. 3208, New
Executive Office Bldg., Washington, DC 20503, Attn: Desk Officer for
FDA.
XI. Request for Comments
Interested persons may, on or before June 21, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. 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 office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 806
Corrections and removals, Medical devices, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 806 be added to read as follows:
PART 806--MEDICAL DEVICE CORRECTIONS AND REMOVALS
Subpart A--General Provisions
Sec.
806.1 Scope.
806.2 Definitions.
Subpart B--Reports and Records
806.10 Reports of corrections and removals.
806.20 Records of corrections and removals not required to be
reported.
806.30 FDA access to records.
806.40 Public availability of reports.
Authority: Secs. 502, 510, 518, 519, 520, 701, 704, and 705 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360h,
360i, 360j, 371, 374, 375).
Subpart A--General Provisions
Sec. 806.1 Scope.
(a) The regulations in this part implement section 519(f) of the
Federal Food, Drug, and Cosmetic Act (the act) which requires device
manufacturers, distributors, and importers to report promptly to the
Food and Drug Administration (FDA) certain actions concerning device
corrections and removals, and to maintain records of all corrections
and removals regardless of whether such corrections and removals are
required to be reported to FDA.
(b) The following actions are exempt from the reporting
requirements of this part:
(1) Actions undertaken by device manufacturers, distributors, and
importers to improve the performance or quality of a device which are
not intended to reduce a risk to health posed by the device or remedy a
violation of the act caused by the device.
(2) Routine servicing as defined in Sec. 806.2(i).
(3) Actions similar to paragraph (b)(1) of this section, undertaken
by manufacturers of general purpose articles, such as chemical reagents
or laboratory equipment whose uses are generally known by persons
trained in their use and which are not labeled or promoted or otherwise
intended for medical use.
(c) The failure of a manufacturer, distributor, or importer or any
person to comply with any applicable requirement of this part renders
the device misbranded within the meaning of section 502(t) of the act
and further constitutes a prohibited act within the meaning of section
301(q)(1)(B) of the act.
Sec. 806.2 Definitions.
The following terms and definitions apply to this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency or FDA means the Food and Drug Administration.
(c) Consignee means any person who received, purchased, or used the
device subject to this part.
(d) Correction means the repair, modification, adjustment,
relabeling, or inspection of a device without its physical removal from
its point of use to another location.
(e) Distributor means any person, including any person who imports
a device into the United States, who furthers the marketing or
distribution of a device from the original place of manufacture to the
person who makes final delivery or sale to the ultimate user, but who
does not repackage or otherwise change the container, wrapper, or
labeling of the device or device package.
(f) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedures. The term includes any person
who:
(1) Repackages or otherwise changes the container, wrapper, or
labeling of a device in furtherance of the distribution of the device
from the original place of manufacture to the person who makes final
delivery or sale to the ultimate user or consumer;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications; or
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed
and are intended to be used as is, or are processed by a licensed
practitioner or other qualified person to meet the needs of a
particular patient.
(g) Removal means the physical removal of a device from the point
of use to some other location for repair, modification, adjustment,
relabeling, destruction, inspection, or replacement.
(h) Risk to health means that the risk of harm to a person for whom
a device is intended exists, and the harm is not trivial. This risk to
health may result from a fault or defect in the device, deficient
labeling, or error in the use of the device.
(i) Routine servicing means any regularly scheduled maintenance of
a device, including the replacement of parts at the end of their normal
life expectancy, e.g., calibration, replacement of batteries, and
responses to normal wear and tear. Repairs of an unexpected nature,
replacement of parts earlier than their normal life expectancy, or
identical repairs or replacements of multiple units of a device are not
routine servicing.
(j) U.S. designated agent means the person designated by the owner
or operator of a foreign establishment responsible for the annual
certification of the number of medical device reports (MDR's)
submitted.
(k) Correction or removal report number means the number that
uniquely identifies each report submitted. Manufacturers, importers, or
distributors shall use their seven digit registration number, the
calendar year that the report is made, a sequence number, and the
report type designation ``C'' or ``R''; for example, the complete
number will appear as follows: 1234567-1993-001-C for correction, or
1234567-1993-001-R for removal.
Subpart B--Reports and Records
Sec. 806.10 Reports of corrections and removals.
(a) Each device manufacturer or distributor shall submit a written
report to FDA of any correction or removal of a device undertaken by
such manufacturer or distributor if the correction or removal was
undertaken:
(1) To reduce a risk to health posed by the device; or,
(2) To remedy a violation of the act caused by the device which may
present a risk to health.
(b) The manufacturer or distributor shall submit any report
required by paragraph (a) of this section within 10 calendar days of
initiating such correction or removal. The report shall be submitted to
the appropriate FDA district office listed in Sec. 5.115 of this
chapter. A foreign manufacturer or distributor that ships devices to
the United States shall submit its own reports of corrective or removal
actions through the U.S. designated agent on its behalf. The U.S.
designated agent shall submit such reports to the district office in
which the agent's office is located.
(c) The manufacturer or distributor shall include the following
information in the report:
(1) The name, address, and telephone number of the manufacturer or
distributor, (including foreign manufacturer), and the name, title,
address, and telephone number of the manufacturer's or distributor's
representative responsible for conducting the device correction or
removal.
(2) The brand name and the common name, classification name, or
usual name of the device and the intended use of the device.
(3) Marketing status of the device, i.e., any applicable premarket
notification number, premarket approval number, or indicate if a
preamendments device, and the device listing number. (A manufacturer or
distributor that does not have an FDA establishment registration number
must indicate in the report whether it has ever registered with FDA).
(4) The correction or removal report number.
(5) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
(6) The manufacturer's name, address, telephone number, and contact
person if different from that of the person submitting the report.
(7) A complete description of the event(s) giving rise to the
information reported and the corrective or removal actions that have
been, and are expected to be, taken.
(8) Any illnesses or injuries that have occurred with use of the
device. If applicable, include the medical device report numbers.
(9) The total number of devices manufactured or distributed and the
number in the same batch, lot, or equivalent unit of production subject
to the correction or removal.
(10) The date of manufacture or distribution and the device's
expiration date if applicable.
(11) The names, addresses, and telephone numbers of all domestic
and foreign consignees of the device and the dates and number of
devices distributed to each such consignee.
(12) A copy of all communications regarding the correction or
removal, and the names and addresses of all recipients of the
communications if the number of recipients of the communications is
different than paragraph (c)(11) of this section.
Sec. 806.20 Records of corrections and removals not required to be
reported.
(a) Each device manufacturer or distributor who undertakes a
correction or removal of a device that is not required to be reported
to FDA under Sec. 806.10 shall keep a record of such correction or
removal.
(b) Records of corrections and removals not required to be reported
to FDA under Sec. 806.10 shall contain the following information:
(1) The brand name, common or usual name, classification name and
product code if known, and the intended use of the device.
(2) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
(3) A complete description of the event giving rise to the
information reported and the corrective or removal action that has
been, and is expected to be taken.
(4) Justification for not reporting the correction or removal
action to FDA shall contain conclusions, any followups, and be reviewed
and evaluated by a designated person.
(5) A copy of all communications regarding the correction or
removal.
(c) The manufacturer or distributor shall retain all records
required to be retained under this section for a period of 2 years
beyond the expected life of the device, even if the manufacturer or
distributor has ceased to manufacture, import, or distribute the
device. Records required to be maintained under paragraph (c) of this
section must be transferred to the new owner of the device and
maintained for the required period of time.
Sec. 806.30 FDA access to records.
Each device manufacturer or distributor required under this part to
maintain records concerning corrections or removals and every person
who is in charge or custody of such records shall, upon request of an
officer or employee designated by FDA and pursuant to section 704(e) of
the act, permit such officer or employee at all reasonable times to
have access to, and to copy and verify, such records and reports.
Sec. 806.40 Public availability of reports.
(a) Any report submitted under this part is available for public
disclosure in accordance with part 20 of this chapter.
(b) Before public disclosure of a report, FDA will delete from the
report:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
and
(2) Any personnel, medical, and similar information, including the
serial numbers of implanted devices, which would constitute a clearly
unwarranted invasion of personal privacy under Sec. 20.63 of this
chapter; provided, that except for the information under Sec. 20.61 of
this chapter, FDA will disclose to a patient who requests a report all
of the information in the report concerning that patient.
Dated: March 17, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-6691 Filed 3-22-94; 8:45 am]
BILLING CODE 4160-01-P
