Medical Devices; Reporting; Certification and U.S. Designated Agents

SUMMARY: The Food and Drug Administration (FDA) is proposing to revise

its regulations for medical device manufacturer certification, and to

issue conforming certification requirements for distributors. FDA is

also announcing its intent to reconsider the requirement for foreign

manufacturers to appoint a U.S. designated agent to perform certain

duties under the adverse event reporting final rule that was published

in the Federal Register of December 11, 1995. FDA is taking this action

in response to comments from industry raising concerns that have not

been addressed previously. Elsewhere in this issue of the Federal

Register, FDA is announcing a stay of the effective date of the

manufacturer certification and U.S. designated agent provisions and the

revocation of the May 28, 1992, distributor certification provisions.

This proposed rule will assist FDA in protecting the public health by

helping to ensure that devices are not adulterated or misbranded and

are safe and effective for their intended uses while reducing the

regulatory burden on reporting entities.

DATES: Submit written comments by October 7, 1996. FDA intends that any

final rule based on this proposal become effective 75 days after

publication of the final rule in the Federal Register.

Submit written comments on the collection of information

requirements by August 22, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

Submit written comments on the information collection requirements

to the Office of Information and Regulatory Affairs, Office of

Management and Budget (OMB), New Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices

and Radiological Health (HFZ-530), Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301-594-2735.

I. Background

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995

(60 FR 63578), FDA published a final rule (parts 803 and 807 (21 CFR

parts 803 and 807)) requiring medical device user facilities and

manufacturers to report adverse events related to medical devices under

a uniform reporting system (hereinafter referred to as the December

1995 final rule). The December 1995 final rule was scheduled to go into

effect on April 11, 1996. On April 11, 1996 (61 FR 16043), FDA

announced that OMB had approved the information collection requirements

in the final rule; FDA also announced an extension of the effective

date of the final rule to July 31, 1996. On May 28, 1992, a distributor

adverse event reporting rule became final. This rule went into effect

by operation of statute without the benefit of notice and comment.

After the issuance of the December 1995 final rule, FDA received

numerous requests for reconsideration of the certification requirements

and reconsideration of issues relating to U.S. designated agent

requirements. These comments led FDA to meet with the Health Industry

Manufacturers Association and several industry representatives on April

19, May 23, and June 13, 1996. During these meetings, issues concerning

industry burden and procedures relating to the certification and U.S.

designated agent requirements were put forth that had not been

considered previously .

To allow further consideration of these issues before

implementation, elsewhere in this issue of the Federal Register, FDA is

publishing a final rule staying the effective date of the manufacturer

certification and U.S. designated agent requirements until the agency

issues a new final rule addressing these issues. This final rule also

revokes the May 28, 1992, distributor certification provisions to

provide uniform manufacturer and distributor certification

requirements.

A. Section 803.57--Annual Certification-

Section 519(d) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 360i(d)) (the act) provides that each manufacturer, importer,

and distributor shall certify that it did file a certain number of

medical device reports (MDR's) in the previous 12 months or it did not

file any MDR reports. The final rule (Sec. 803.57) required

manufacturers through their president, chief executive officer

(C.E.O.), U.S. designated agent of a foreign manufacturer, or other

official most directly responsible for the firm's operations, to

certify that they filed MDR's for all reportable events required under

the rule for the previous 12 months and a numerical summary of MDR's

that they submitted, or that they did not receive any reportable events

during the reporting period.

Industry representatives objected to the corporate status of the

person required to certify, as well as the content of the certification

statement itself. Industry representatives objected to requiring the

C.E.O. or president to certify, because, especially in a large company,

that person may not be familiar with the details of the MDR reporting

program. Industry representatives also objected to the requirement that

they certify that they filed reports for all reportable events during

the reporting period. Industry representatives objected that this

requirement was not supported by the language of section 519(d) of the

act and objected to potential liability that may arise from

certification that all reportable events had been submitted, if there

were unintentional reporting mistakes.

In the December 1995 final rule, FDA required the certification

that all MDR reportable events were filed on the basis of the statute's

legislative history. The legislative history of section 519(d) of the

act states that Congress included this provision on the recommendation

of the General Accounting Office (GAO) as an important means of

increasing the effectiveness of the MDR system. (See H. Rept. 808,

101st Congress, 2d sess. 23, (1990); S. Rept. 513, 101st Congress, 2d

sess. 26, (1990)). The GAO report noted that certain information

indicated that a third of the establishments inspected were not even

aware that the MDR reporting requirements existed (GAO/PEMD-89-10,

``FDA's Implementation of the Medical Device Reporting Regulation,'' p.

4). The GAO report recommended certification to ensure that all

manufacturers and importers be made aware of their obligation to submit

MDR's and to identify those firms that were not aware of their

obligation (id. at pp. 5 and 69). The legislative history of section

519(d) of the act also cites the GAO report recommendation that the

certification state that the reporter filed a specific number of

reports and that the firm received or became aware of only these

reports (H. Rept. 808, 101st Congress, 2d sess. 23).

[[Page 38349]]

FDA believes that its regulation implementing the certification

requirements was within the scope of the statutory authority provided

in section 519(d) of the act. FDA, however, in response to the comments

objecting to the person required to certify and to the content of the

certification, has reexamined the certification requirement and

believes that the regulation may be revised in a manner that will

address the main concerns raised about the regulation and still meet

the intent of section 519(d) of the act that will improve MDR

efficiency by making firms aware of their reporting obligations under

MDR.

FDA designated in the December 1995 final rule that the certifier

must be the president, C.E.O., U.S. designated agent, or other official

most directly responsible for the firm's operations, in response to a

comment to the tentative final rule (56 FR 60024, November 26, 1991)

requesting FDA to identify who should certify. FDA now believes,

however, based on subsequent comments received, that it may be

appropriate for someone other than the president or chief executive

officer to sign the certification statement. FDA believes that the

proposal suggested by the comments to place this particular

responsibility of certification with the same individual in whom the

company has already vested overall responsibility for implementing and

overseeing its MDR program may be more appropriate than requiring

certification by the president or C.E.O. FDA, therefore, is proposing

to revise Sec. 803.57 to provide that the manufacturer shall designate,

as the certifying official, an individual with oversight

responsibilities for, and knowledge of, the firm's medical device

reporting system.

This proposal also provides that, based upon its organizational

structure, a firm may designate more than one certifying official, each

of whom would sign a certification statement for his or her identified

organizational component or site. This provision is designed to provide

needed flexibility to large companies with more than one operating

division or medical device reporting site.

Regarding the content of the certification, FDA is proposing to

amend Sec. 803.57 to require that the individual certifying for the

firm state that: (1) He/she has read the requirements of the MDR

regulation, (2) the firm has established a system to implement medical

device reporting; and (3) following the procedures of its medical

device reporting system, the firm submitted a specified number of

reports, or no reports, during the certification period.

FDA believes that this certification statement is a reasonable

application of the intent of section 519(d) of the act. The legislative

intent is to improve compliance with the MDR reporting requirements by

making responsible persons within medical device companies fully aware

of the MDR reporting requirements. This intent may be reasonably

accomplished by requiring a responsible company official to certify

that: (1) He/she has read the MDR regulation, (2) the company has put

in place a system to implement those regulations, and (3) a specified

number of MDR reports were submitted during the previous year as a

result of its implementation system.

Under proposed Sec. 803.57(a), the dates of certification would

remain the same as the December 1995 final rule, i.e., the date of the

firm's annual registration. FDA intends that the first certification

statement would be due with the first annual registration due at least

6 months after the effective date of the final rule. For example, if

the final rule were to become effective in March 1997, the first group

of certifications would be due with annual registrations due in

September 1997 and would cover a 6-month period. The next group of

annual certifications would be due in December 1997 and would cover a

9-month period. Annual certifications due in April 1998 or later would

cover a 12-month period. Foreign manufacturers would be required to

submit their certification with the annual registration, if they

voluntarily register, or in accordance with the schedule in

Sec. 807.21(a).

B. Section 803.58--Foreign Manufacturers

Section 803.58 of the December 1995 final rule required that

foreign manufacturers designate a U.S. agent to be responsible for

reporting under part 803. U.S. designated agents were to be responsible

for: (1) Reporting to FDA in accordance with Secs. 803.50, 803.52,

803.53, 803.55, and 803.56; (2) conducting, or obtaining from the

foreign manufacturer, the necessary information regarding the

investigation and evaluation of the event under the requirements of

Sec. 803.50; (3) certifying in accordance with Sec. 803.57; (4)

forwarding MDR complaints to the foreign manufacturer and maintaining

documentation of this requirement; (5) maintaining complaint files in

accordance with Sec. 803.18; and (6) registering, listing, and

submitting premarket notifications in accordance with part 807.

After the issuance of the December 1995 final rule, manufacturers

who began to implement arrangements with U.S. designated agents stated

that it was difficult to find individuals willing to take on the duties

of a U.S. designated agent and that fees were high for those willing to

take on the duties. Manufacturers noted particular concern about the

appropriateness of a U.S. designated agent providing certifications

related to MDR's and premarket notification requirements because they

believed that the U.S. designated agent may not be able to accurately

provide such certifications. Moreover, the potential liability

associated with certification responsibilities greatly increased the

cost of U.S. designated agent services.

In addition to the concerns discussed previously, many other issues

relating to the implementation and scope of U.S. designated agent

requirements were raised for the first time after the December 1995

final rule. After further internal discussions, FDA decided to stay the

effective date of these requirements, as noted elsewhere in this issue

of the Federal Register, until further notice and comment proceedings

and the issuance of a new rule.

In the interim, foreign manufacturers have a responsibility for

compliance with all medical device reporting requirements which will

not be affected by the stay of the effective date of the U.S.

designated agent requirements. This is because the December 1995 final

rule contained a significant change regarding foreign manufacturers.

The original MDR regulation that became effective December 13, 1984,

applied only to manufacturers that were required to register under part

807. Because foreign manufacturers are not required to register, the

1984 rule did not apply to them. The December 1995 final rule, however,

applies to manufacturers regardless of whether they are required to

register under part 807. Rather, under Sec. 803.3(n) of the December

1995 final rule, a manufacturer means any person who manufactures,

prepares, propagates, compounds, assembles, or processes a device by

chemical, physical, biological, or other procedure. Accordingly,

foreign manufacturers clearly fit within the definition of

manufacturers who are required to submit MDR's under the December 1995

final rule. Therefore, on July 31, 1996, foreign manufacturers will be

fully subject to the same requirements of part 803 applicable to

domestic manufacturers. This includes, but is not limited to, the

requirements for written procedures (Sec. 803.17), MDR event files

(Sec. 803.18), individual adverse

[[Page 38350]]

event reports (Secs. 803.50 and 803.52), five-day reports

(Sec. 803.53), baseline reports (Sec. 803.55), and supplemental reports

(Sec. 803.56).

The stayed provisions for U.S. designated agents would have

required that these functions be performed by a U.S. designated agent

on behalf of the foreign firm. Because FDA is staying the effective

date of the U.S. designated agent requirement, the full responsibility

for reporting is now the obligation of the foreign manufacturer.

Beginning July 31, 1996, foreign manufacturers are required to submit

MDR reports directly to FDA (except for certification). In addition,

existing registration, listing, and premarket notification regulations,

which will remain in effect during the stay, permit foreign

manufacturers to register (Sec. 807.40(a)) and submit premarket

notifications (Sec. 807.81) and require them to list their devices.

(Sec. 807.40(b)).

FDA is reconsidering the duties of a U.S. designated agent. As

noted in the preamble to the December 1995 final rule, FDA intends to

issue a proposed rule to revoke the reporting requirements for

distributors, including importers, (part 804 (21 CFR part 804)) and

replace them with requirements consistent with the new manufacturer and

user facility reporting requirements under part 803. Because importers

may be able to play a role, in whole or in part, that was assigned to

the U.S. designated agent in the December 1995 final rule, FDA believes

that it would be appropriate to address the issue of U.S. designated

agents at the same time the agency reproposes requirements for

distributors and importers generally.

FDA included the U.S. designated agent requirement in the December

1995 final rule in order to assure that foreign and domestic

manufacturers are treated equally and that FDA has access to the same

information it has from domestic manufacturers that will enable the

agency to protect the public health. To this end, FDA listed certain

duties in the December 1995 final rule that a U.S. designated agent

would be required to perform as described above. FDA solicits comments

on who may best perform these duties and specifically seeks comments on

the following points:

1. What person is best situated to perform the following duties

that, in the December 1995 final rule, were assigned to the U.S.

designated agent on behalf of the foreign manufacturer: (1) Reporting

to FDA in accordance with Secs. 803.50, 803.52, 803.53, 803.55, and

803.56; (2) conducting, or obtaining from the foreign manufacturer the

necessary information regarding the investigation and evaluation of the

event under the requirements of Sec. 803.50; (3) certifying in

accordance with Sec. 803.57; (4) forwarding MDR complaints to the

foreign manufacturer and maintaining documentation of this requirement;

(5) maintaining complaint files in accordance with Sec. 803.18; and (6)

registering, listing, and submitting premarket notifications in

accordance with part 807?

2. Should FDA require a foreign manufacturer to designate a U.S.

agent to fulfill the role of an ``official correspondent'' with FDA

regarding MDR reporting and other regulatory issues (e.g., product

listing)? The intent of this function would be to ensure that FDA can

easily contact foreign firms on MDR issues and communicate in English

with them, particularly on urgent public health matters.

3. Should FDA require foreign manufacturers to designate a U.S.

agent for the purpose of fulfilling their substantive U.S. MDR

obligations regarding complaint investigations, reporting, and

maintenance of MDR files? The intent of this function would be for FDA

to be able to monitor MDR compliance of foreign firms without

conducting a costly overseas inspection.

4. Can either of these functions readily be carried out by

importers, or by other means, so that foreign manufacturers would not

be required to enter into contractual arrangements with new entities?

5. How can these functions be carried out efficiently by foreign

manufacturers who distribute devices into the United States by multiple

importers, and how can FDA be routinely informed of all importers of a

firm annually or on an as needed basis?

Notwithstanding FDA's intent to repropose these requirements, the

agency has already tentatively concluded that it should propose that

two aspects of the U.S. designated agent regulations be deleted. The

first is the requirement for U.S. designated agents to issue the annual

certification required under Sec. 803.57. Upon reconsideration, FDA

believes it is more appropriate for the foreign manufacturer to issue

this certification as proposed in this rule. The other is the

requirement for foreign manufacturers to submit premarket notifications

(510(k)'s) through U.S. designated agents. Although the agency had

hoped this provision would help resolve 510(k) ownership issues

regarding foreign manufacturers, FDA is persuaded that the costs

imposed by this requirement are not likely to outweigh the possible

benefits. FDA solicits comment on its intent to propose to delete these

two parts of the U.S. designated agent regulations.

III. 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.

IV. Analysis of Impacts

FDA has examined the economic impact of the proposed rule under

Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C.

22601-612). Executive Order 12866 directs agencies to assess all costs

and benefits of available regulatory alternatives and, when regulation

is necessary, to select regulatory approaches that maximize net

benefits including potential economic, environmental, public health and

safety, and other advantages; distributive impacts; and equity. The

agency believes that the proposed rule is consistent with the

principles set out in the Executive Order.

If a rule has a significant economic impact on a substantial number

of small entities, the Regulatory Flexibility Act requires agencies to

analyze regulatory options that would minimize any significant impact

of the rule on small entities. The proposed rule would apply to all

medical device manufacturers and distributors whose devices are sold in

the United States. The proposed rule would relieve two regulatory

burdens. It would allow the certification statement to be signed by the

person most familiar with the MDR program, not necessarily the

president or C.E.O. It also changes the certification statement to

minimize the possibility of liability as a result of an unintended

mistake in reporting. Therefore, under the Regulatory Flexibility Act,

5 U.S.C. 2605(b), the Commissioner of Food and Drugs certifies that the

proposed rule, if finalized, will not have a significant economic

impact on a substantial number of small entities.

V. Paperwork Reduction Act of 1995

This proposed rule contains information collections which are

subject to review by OMB under the Paperwork Reduction Act of 1995

(Pub. L. 104-13). The title, description, and respondent description of

the information collections are shown below along with an estimate of

the annual record keeping and periodic reporting burden. Included in

the estimate is the time for reviewing

[[Page 38351]]

instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information.

Title: Reporting and record keeping requirements for user

facilities, distributors, and manufacturers of medical devices under

the Safe Medical Devices Act of 1990 and the Medical Device Amendments

of 1992 (General Requirements).

Description: This regulation proposes to amend regulations

regarding device manufacturer and distributor reporting of deaths,

serious injuries, and certain malfunctions related to medical devices.

The purpose of these changes is to improve the protection of the public

health while also reducing the regulatory burden on reporting entities.

The rule amends information collection requirements which have been

approved under OMB no. 0910-0059.

Description of Respondents: Businesses or other for profit

organizations, nonprofit organizations, Federal, State, and local

governments.

TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN

----------------------------------------------------------------------------------------------------------------

Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

803.57 12,000 1 12,000 1 12,000

804.30 8,200 1 8,200 1 8,200

Total 20,200 20,000 20,200

----------------------------------------------------------------------------------------------------------------

There are no capital or operating and maintenance costs expected as

a result of this proposal.

Under OMB information collection no. 0910-0059, which expires on

February 28, 1999, a total of 187,610 burden hours were approved for

collection of information requirements in the December 11, 1995, final

rule (60 FR 63578) on medical device user facility and manufacturer

reporting, certification and registration. The 12,000 burden hours

reported above in Table 1 for Sec. 803.57 were included in that

approval and therefore do not affect the total number of approved

burden hours. However, the 8,200 burden hours reported in Table 1 for

Sec. 804.30 have not previously been considered in an information

collection submission to OMB, and do represent an increase in the

burden. Therefore, this proposed rule would add 8,200 hours to the

existing approved burden and would result in a proposed total annual

information collection burden of 195,810 hours (187,610 + 8,200 =

195,810).

Therefore, the agency solicits public comments on the revised

information collection requirements in order to: (1) Evaluate whether

the proposed collection of information is necessary for the proper

performance of the functions of the agency, including whether the

information will have practical utility; (2) evaluate the accuracy of

the agency's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) enhance the quality, utility, and clarity of the information

to be collected; and (4) minimize the burden of the collection of

information on those who are to respond, including through the use of

appropriate automated, electronic, mechanical, or other technological

collection techniques or other forms of information technology, e.g.,

permitting electronic submission of responses.

As required by section 3507(d) of the Paperwork Reduction Act of

1995, FDA has submitted a copy of the proposed rule amending parts 803

and 804 to OMB for its review of the revised information collection

requirements. Other organizations and individuals interested in

submitting comments regarding this burden estimate or any aspect of

these information collection requirements, including suggestions for

reducing the burden, should direct them to the Office of Information

and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA.

Written comments on the information collections should be submitted by

August 22, 1996.

List of Subjects in 21 CFR Parts 803 and 804

Imports, Medical devices, Reporting and record keeping

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 parts 803 and 804 amended as follows:

PART 803--MEDICAL DEVICE REPORTING

1. The authority citation for part 803 continues to read as

follows:

Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371,

374).

2. Section 803.1 is amended by revising paragraph (a) to read as

follows:-

Sec. 803.1 Scope.

(a) This part establishes requirements for medical device

reporting. Under this part, medical device user facilities and

manufacturers must report deaths and serious injuries to which a device

has or may have caused or contributed, and manufacturers must also

report certain device malfunctions. Additionally, user facilities and

manufacturers must establish and maintain adverse event files, and must

submit to FDA specified followup and summary reports. These reports

will assist FDA in protecting the public health by helping to ensure

that devices are not adulterated or misbranded and are safe and

effective for their intended use.

* * * * *

3. Section 803.57 is revised to read as follows:

Sec. 803.57 Annual certification.

(a) All manufacturers required to report under this section shall

submit an annual certification report to FDA, on FDA Form 3381, or

electronic equivalent as approved under Sec. 803.14. The date for

submission of certification coincides with the date for the firm's

annual registration, as designated in Sec. 807.21 of this chapter.

Foreign manufacturers shall submit their certification by the date on

which they would be required to register under Sec. 807.21 of this

chapter if they were domestic manufacturers. The certification period

will be the 12-month period ending 1 month before the certification

date.

(b) The manufacturer shall designate, as the certifying official,

an individual with oversight responsibilities for, and knowledge of,

the firm's medical device reporting system. A manufacturer may

determine, based upon its organizational structure, that one individual

cannot oversee or have

[[Page 38352]]

complete knowledge of the operation of the reporting system at all

organizational components or manufacturing sites owned by the firm. In

this circumstance, the firm may designate more than one certifying

official, each of whom will sign a certification statement pertaining

to their respective identified organizational component(s) or site(s).

(c) The report shall contain the following information:

(1) Name, address, telephone number, and FDA registration number or

FDA---assigned identification number of the reporting site and whether

the firm is a manufacturer;

(2) Name, title, address, telephone number, signature, and date of

signature of the person making the certification;

(3) Name, address, and FDA registration number of each

manufacturing site covered by the certification and the number of

reports submitted for devices manufactured at each site;

(4) A statement certifying that:

(i) The individual certifying for the firm has read the MDR

requirements under part 803;

(ii) The firm has established a system to implement medical device

reporting; and

(iii) Following the procedures of its medical device reporting

system, the reporting site submitted the specified number of reports,

or no reports, during the 12-month certification period.

(d) The name of the manufacturer and the registration number

submitted under paragraph (c)(1) of this section shall be the same as

the reporting site that submitted the reports required by Secs. 803.52,

803.53 and 803.55. Multi-reporting site manufacturers who choose to

certify centrally must identify the reporting sites, by registration

number or FDA-assigned identification number and name covered by the

certification, and provide the information required by paragraph (c)(2)

and (c)(3) of this section for each reporting site.

PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING

4. The authority citation for part 804 continues to read as

follows:

Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371,

374).

5. Part 804 is amended by adding new Sec. 804.30 to read as

follows:

Sec. 804.30 Annual certification.

(a) Distributors required to report under this section shall submit

an annual certification report to FDA on form FDA 3381, or electronic

equivalent as approved under Sec. 803.14 of this chapter. The date for

submission of certification coincides with the date for the firm's

annual registration as designated in Sec. 807.21 of this chapter. This

certification period will be the 12-month period ending 1 month before

the certification date.

(b) The distributor shall designate, as the certifying official, an

individual with oversight responsibilities for, and knowledge of, the

firm's medical device reporting system. A distributor may determine,

based upon its organizational structure, that one individual cannot

oversee or have complete knowledge of the operation of the reporting

system at all organizational components or distribution sites owned by

the firm. In this circumstance, the firm may designate more than one

certifying official (one for each component or site), each of whom will

sign a certification statement pertaining to their respective

identified organizational component(s) or site(s).

(c) The report shall contain the following information:

(1) Name, address, telephone number, and FDA registration number or

FDA assigned identification number of the firm;

(2) Name, title, address, telephone number, signature, and date of

signature of the person making the certification;

(3) Name, address, and FDA registration number of the distributor

covered by the certification and the number of reports submitted for

devices distributed by the distributor;

(4) A statement certifying that;

(i) The individual certifying for the firm has read the MDR

requirements under part 804;

(ii) The firm has established a system to implement medical device

reporting; and,

(iii) Following the procedures of its medical device reporting

system, the firm submitted the specified number of reports, or no

reports, during the 12-month certification period.

Dated: July 16, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-18701 Filed 7-19-96; 2:26 pm]

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