[Federal Register Volume 62, Number 54 (Thursday, March 20, 1997)]
[Rules and Regulations]
[Pages 13302-13306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 803 and 804

[Docket No. 91N-0295]
RIN 0910-AA09


Medical Devices; Medical Device Reporting; Annual Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its medical 
device manufacturer and distributor adverse event certification 
regulations. The revised certification requirements allow manufacturers 
and distributors to designate more than one certifying official, who 
would each sign a certification statement for his or her identified 
organizational component or site; amend the certification statement to 
minimize concerns relating to liability from unintentional reporting 
errors; and indicate that the certifying official is making the 
certification statements, to the best of his/her knowledge and belief. 
This action is being taken to help FDA carry out its public health 
protection responsibilities relating to medical devices. This action 
provides reporting entities with greater flexibility in the 
certification process while reducing the regulatory burden.

DATES: Effective May 19, 1997. Submit written comments on the 
information collection requirements by April 21, 1997.

ADDRESSES: Submit written comments on the final rule 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 519(d) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i(d)) provides that each manufacturer, importer, and 
distributor shall certify that they did file a certain number of 
medical device reports (MDR's) in the previous 12 months or they did 
not file any MDR's. Distribution certification regulations implementing 
this statutory provision became effective on May 28, 1992, when 
requirements relating to distributor reporting that were proposed in 
the Federal Register of November 26, 1991 (56 FR 60024), became final 
by operation of law. In the Federal Register of December 11, 1995 (60 
FR 63578), FDA published a final rule similar to the distributor 
certification provisions, that required manufacturers to submit 
certification statements (Sec. 803.57 (21 CFR 803.57)) (hereinafter 
referred to as the December 1995 final rule). Distributors and 
manufacturers were required to certify that they filed reports for all 
reportable events required under

[[Page 13303]]

the rule for the previous 12 months or to certify that they did not 
receive any reportable events during the reporting period (Sec. 803.57 
and 804.30 (21 CFR 804.30). The December 1995 final rule required 
certification to be made by the company's president, chief executive 
officer (C.E.O.), the U.S. designated agent, or other official most 
directly responsible for the firm's operations. The effective date of 
this regulation was to be April 11, 1996. In the Federal Register of 
April 11, 1996 (61 FR 16043), FDA extended the effective date to July 
31, 1996.
    Subsequent to the issuance of the December 1995 final rule, 
industry representatives objected to the corporate status of the person 
required to certify as well as the content of the certification 
statement itself. On April 19, May 23, and June 13, 1996, FDA held 
meetings with the Health Industry Manufacturers Association and several 
industry representatives. During these meetings, industry objected to 
requiring the C.E.O. or president to certify, because, especially in a 
large company, that person would 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 
asserted that this requirement was not supported by the language of 
section 519(d) of the act. Moreover, industry representatives asserted 
that it would be impossible to certify that they submitted all 
``reportable'' events because that would be a subjective conclusion and 
there could be honest disagreements between FDA and the manufacturer as 
to whether a particular event was a ``reportable'' event. Accordingly, 
industry representatives viewed the subjective nature of the 
certification statement as placing corporate officials in an untenable 
position with respect to their liability.
    In response to industry concerns, the agency reviewed its position 
in light of the statutory language and legislative history. In the 
Federal Register of July 23, 1996 (61 FR 38346), the agency stayed the 
effective date of the certification requirement of the December 1995 
final rule. In that same issue of the Federal Register (61 FR 63548), 
the agency reproposed a new certification requirement.
    As discussed more fully in the preamble of the July 23, 1996, 
proposal, and in response to the comments below, the legislative 
history of section 519(d) of the act shows that the intent of Congress 
was to improve MDR efficiency by making firms more aware of their 
reporting obligations under MDR. The preamble of the proposed rule also 
stated that although FDA believed that the certification provision in 
its December 1995 final rule was within the scope of the statutory 
authority provided by section 519(d) of the act, FDA believed that the 
proposed modified certification provision would address the concerns 
expressed about the existing certification provisions and still meet 
the intent of section 519(d) of the act.
    The July 23, 1996, proposed rule provided that the firms would be 
required to designate, as the certifying official, an individual with 
oversight responsibilities for, and knowledge of, the firm's MDR 
reporting system. The proposal also provided 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/her 
identified organizational component or site. The proposal would have 
required the individual certifying for the firm to state that: (1) He/
she has read the requirements of the MDR regulation; (2) the firm has 
established a system to implement MDR reporting; and (3) following the 
procedures of its MDR reporting system, the firm submitted a specified 
number of reports, or no reports, during the certification period.
    After reviewing the comments discussed below, FDA is now issuing a 
final rule based upon the proposed certification requirements, amended 
only by the additional statement that the certifying official is making 
the certification statements ``to the best of [his/her] knowledge and 
belief.'' In framing the certification in this way, the agency has 
attempted to eliminate industry's concern about potential liability for 
inadvertent errors, by requiring certification of objective statements 
to the best of the certifier's knowledge. It is a factual matter as to 
whether the certifier has read the MDR regulation, whether the company 
has established a system to implement those regulations, and how many 
MDR's the company submitted to FDA as a result of following that 
system. At the same time, FDA believes that this certification 
statement is a reasonable requirement that will achieve the intent of 
section 519(d) of the act by making reporters more aware of their MDR 
obligation, and will result in corporate management taking active 
responsibility for its MDR program. To implement section 519(d) of the 
act, FDA believes the regulation is reasonable in requiring a 
responsible company official to certify to the best of his/her 
knowledge and belief, that he/she has read the MDR regulation, that 
there is a system in place to implement those regulations, and that a 
specific number of reports were submitted under that system.
    The agency is also taking this opportunity to stress the importance 
of certification by all firms covered under this rule, and by all sites 
or organizational components of such firms, if more than one certifying 
official is designated. The agency recognizes that, depending upon the 
organizational structure of a medical device firm, one certifying 
official may not be able to oversee or have complete knowledge of the 
operation of all components or sites owned by the firm. For this 
reason, the agency proposed that, in this circumstance, the firm may 
designate more than one certifying official, who will each sign a 
certification statement pertaining to his/her respective identified 
components or sites. The agency is taking this opportunity to clarify 
that, if the firm designates more than one certifying official, all 
organizational components or sites must be assigned to an appropriate 
certifying official, so that all sites and components of a firm are 
covered under a certification statement. The final rule has been 
modified to clarify this concept.

II. Summary of Comments

    1. The agency received five comments on the July 23, 1996, proposed 
rule, submitted by manufacturers, industry representatives, and 
industry associations. Four of these comments were in strong support of 
the proposed changes. These comments praised the agency for its 
responsiveness and its appreciation of the diversity of the medical 
device industry. Specifically, these comments approved of the 
designation of responsible certifying official or officials who would 
have the most direct knowledge of the adverse event reporting process. 
Although these comments also noted that there may still be some 
question as to whether the certification statement exceeds the 
statutory requirement, because these comments found the certification 
statement to be reasonable, the comments requested only one change to 
the certification statement--the inclusion of the words ``to the best 
of my knowledge.''
    The agency agrees with these comments and has modified the 
certification statement accordingly. The agency has already 
acknowledged that certifications should be made to the best knowledge 
of the certifier. In the April 11, 1996, Federal Register document 
announcing the Office of Management and Budget (OMB) approval of MDR

[[Page 13304]]

reporting forms, and extending the effective date of the MDR final 
rule, FDA concluded it would be reasonable to include the qualifying 
phrase ``to the best of my knowledge'' in this type of certification 
statement (see 61 FR 16043 at 16045). Likewise, in the certification 
statement submitted as part of a premarket notification, the agency has 
included language stating that the statement is made to the best of the 
certifier's knowledge (see 21 CFR 807.94(a)). Accordingly, the MDR 
certification statement, as modified in this final rule, now contains 
language that ``the certification is made to the best of the certifying 
official's knowledge and belief.''
    2. The remaining comment believed the proposed certification 
statement was not reasonable. This comment maintained that the agency 
does not have statutory authority to require any more than 
certification of the number of reports submitted. Furthermore, this 
comment found the proposed certification statement to be ambiguous and 
requested clarification of several terms and concepts.
    Specifically, this comment questioned whether, when the certifying 
official states that he/she has ``read the requirements of the MDR 
regulation,'' this would be interpreted to mean that the official is 
knowledgeable and understanding of the regulation and associated 
guidance documents. The comment objected to this interpretation because 
the certifying official would be at risk if he/she had read the 
regulation, but did not understand all the finer points of the intent 
or requirements of the regulation or supporting documents.
    Likewise, this comment questioned whether the certification 
statement, which states that ``the firm has established a system to 
implement medical device reporting,'' may be interpreted by the agency 
to impute that such system is ``adequate,'' and thereby put the 
certifying official at risk, as one reporting error would render the 
reporting system inadequate. According to the comment, the same error 
in reporting would put the certifying official at risk when he/she 
certifies that ``following the procedures of its medical device 
reporting system'' certain reports were filed. This comment also 
expressed concern that the certifying official may be at risk if the 
agency disagrees with the manufacturer's determination that certain 
events are not reportable. The comment then suggested alternative 
wording to the certification statement designed to obviate these 
concerns.
    The agency disagrees with the comment that the certification 
statements are ambiguous and create the risks described above to the 
certifier. The certification requirement simply requires the certifier 
to attest to certain facts, i.e., that he/she has read the MDR 
reporting requirements, that the firm has established MDR reporting 
systems to implement those requirements, and that those procedures were 
followed in submitting the MDR's. Certification to these facts does not 
add any additional liability to the certifier for reporting errors. 
However, as noted above, to alleviate concern that the proposed 
certification statements may subject certifiers to liability for 
inadvertent or good faith errors, FDA has adopted the suggestion of 
several comments by qualifying the certification with the statement 
that ``the certification is made to the best of the certifying 
official's knowledge and belief.'' FDA believes that this change 
appropriately addresses these concerns.
    FDA also does not agree that the revised final regulation is beyond 
the statutory authority provided under section 519(d) of the act. 
Section 519(d) of the act requires that each manufacturer, importer, 
and distributor annually certify the number of MDR's or that no reports 
were filed. FDA disagrees with the comments' interpretation that this 
provision limits FDA's authority to issue a regulation to require 
certification solely of the number of MDR's filed or that no MDR's were 
filed. FDA's final regulation, which requires that the person filing 
the certification has read the MDR reporting requirements, that the 
firm has established a system to implement MDR reporting requirements, 
and that following these procedures a certain number of MDR's were 
filed or that no MDR's were filed, is well within the ambit of section 
519(d) of the act.
    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 Cong., 2d 
sess., 23 (1990); S. Rept. 513, 101st Cong., 2d sess. 26 (1990)). The 
GAO report noted that certain information indicated that a third of 
establishments inspected were not even aware that the MDR reporting 
requirements existed (1989 GAO Report entitled ``FDA's Implementation 
of the MDR 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. pp. 5 and 69).
    The legislative history of section 519(d) of the act indicates that 
Congress' clear intent in requiring certification was to ensure that 
those required to report MDR's were aware of those requirements. FDA 
does not believe that requiring certification of solely the number of 
MDR's filed or that no MDR's were filed, adequately achieves this 
purpose. The final regulation ensures that firms are aware of the 
requirements by requiring firms to certify that a responsible person 
has read the requirements, the firm has established a system to 
implement these requirements, and this system was followed in 
submitting MDR's. In that the final regulation is consistent with the 
intent of Congress to make reporters aware of their obligations, FDA 
believes that the final regulation is fully within the ambit of section 
519(d) of the act.

III. Implementation

    Under final Secs. 803.57(a) and 804.30(a), the agency has retained 
the schedule for submitting certification as established by the 
December 1995 final rule. The schedule for submitting annual 
certifications shall correspond with the schedule provided in 
Sec. 807.21 (21 CFR 807.21(a)) for firm registrations, and must be 
followed by all firms required to certify regardless of whether the 
firm is required to register. Under this schedule, annual 
certifications will be due in either April, July, September, or 
December, depending on the first letter of the name of the owner or 
operator of the reporting firm. FDA intends that the first group of 
certifications will be due at the same time the first annual 
registrations would be due, at least 6 months after the effective date 
of the final rule.
    According to this schedule, the first group of annual 
certifications will be due in April 1998, for firms whose owner or 
operator name begins with the letters A-E. This first group of 
certifications will certify to MDR's submitted between the effective 
date of this rule and March 1998. The second group of annual 
certifications will be due in July 1998, for firms whose owner or 
operator name begins with the letters F-M. This group of certifications 
will certify to MDR's submitted between the effective date of this rule 
and June 1998. The third group of annual certifications will be due in 
September 1998, for firms whose owner or operator name begins with the 
letters N-R, and will certify to MDR's submitted between the effective 
date of this rule and August 1998. The final group in this series of 
annual certifications will be due in December 1998, for firms whose 
owner or operator name begins with the letters S-Z, and

[[Page 13305]]

will certify to MDR's submitted between the effective date of this rule 
and November 1998.
    After the initial certifications, firms shall submit certification 
reports annually, certifying to the MDR's submitted in the previous 12-
month period ending 1 month prior to the month the certification is 
due, consistent with the schedule provided in Sec. 807.21(a).

IV. Analysis of Impacts

    FDA has examined the economic impact of the final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
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 this rule is consistent with the principles identified 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 a rule on small entities. This rule applies to all medical device 
manufacturers and distributors whose devices are sold in the United 
States. The rule relieves two regulatory burdens. It allows 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 industry's concern 
about the possibility of liability as a result of an unintended mistake 
in reporting. Therefore, under the Regulatory Flexibility Act, the 
Commissioner of Food and Drugs certifies that this final rule does not 
have a significant economic impact on a substantial number of small 
entities.

V. Paperwork Reduction Act of 1995

    This 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 recordkeeping and periodic reporting 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: Reporting and recordkeeping 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 amends 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. This rule amends 
information collection requirements which have been approved under OMB 
No. 0910-0059.
    Description of Respondents: Businesses or other for profit 
organizations, Federal, State, and local Governments.

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      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         ..............   20,200         ..............   20,200       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs expected as a result of this rule.                

    Under OMB 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 1995 final rule 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 the 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 (distributor reporting) have 
not previously been considered in an information collection submission 
to OMB, and do represent an increase in the burden. Therefore, this 
rule would add 8,200 hours to the existing approved burden and would 
result in a total annual information collection burden of 195,810 hours 
(187,610 + 8,200 = 195,810).
    In the July 23, 1996, proposed rule, the agency solicited 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.
    Individuals and organizations may submit written comments on the 
information collection requirements by April 21, 1997. Written comments 
on the final rule should be submitted to the Dockets Management Branch 
(address above).
    The agency received one comment recommending an alternative format 
for the form associated with this reporting. Although the alternative 
format would not affect the reporting burden, the agency is considering 
the suggested modifications to the form.

List of Subjects in 21 CFR Parts 803 and 804

    Imports, 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, 21 CFR 
parts 803 and 804 are amended as follows:

[[Page 13306]]

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, except that the first certification period shall cover at least a 
6-month period from the effective date of this section, 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 MDR reporting system. A manufacturer 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 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 his/her respective identified organizational component(s) or 
site(s), provided that all organizational components and sites are 
covered under a certification statement.
    (c) The report shall contain the following information:
    (1) Name, address, 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 or FDA assigned 
identification number for 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 this part;
    (ii) The firm has established a system to implement MDR reporting;
    (iii) Following the procedures of its MDR reporting system, the 
reporting site submitted the specified number of reports, or no 
reports, during the certification period; and
    (iv) The certification is made to the best of the certifying 
official's knowledge and belief.
    (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. Multireporting site manufacturers who choose to 
certify centrally must identify the reporting sites, by registration 
number and name covered by the certification, and provide the 
information required by paragraphs (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. New Sec. 804.30 is added to read as follows:


Sec. 804.30  Annual certification.

    (a) All distributors 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 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. The certification period will be the 12-month period ending 1 
month before the certification date, except that the first 
certification period shall cover at least a 6-month period from the 
effective date of this section, 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 MDR 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), provided that all 
organizational components and sites are covered under a certification 
statement.
    (c) The report shall contain the following information:
    (1) Name, address, 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 or FDA assigned 
identification number for 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 MDR reporting;
    (iii) Following the procedures of its MDR reporting system, the 
firm submitted the specified number of reports, or no reports, during 
the certification period; and
    (iv) The certification is made to the best of the certifying 
official's knowledge and belief.

    Dated: March 12, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-7001 Filed 3-19-97; 8:45 am]
BILLING CODE 4160-01-F