[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
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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
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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
