Medical Devices; Reports of Corrections and Removals; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES

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