[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]


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Part V





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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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