[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)]
[Proposed Rules]
[Pages 38348-38352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18701]
Federal Register / Vol. 61, No. 142 / Tuesday, July 23, 1996 /
Proposed Rules
[[Page 38348]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803 and 804
[Docket No. 96N-0241]
RIN 0910-AA09
Medical Devices; Reporting; Certification and U.S. Designated
Agents
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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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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