[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Rules and Regulations]
[Pages 26069-26077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12614]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803 and 804
[Docket No. 98N-0170]
Medical Device Reporting: Manufacturer Reporting, Importer
Reporting, User Facility Reporting, and Distributor Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing reporting by manufacturers, importers,
distributors, and health care (user) facilities of adverse events
related to medical devices. Amendments are being made to implement
revisions to the Federal Food, Drug, and Cosmetic Act (the act) as
amended by the Food and Drug Administration Modernization Act of 1997
(FDAMA). FDA is publishing these amendments in accordance with its
direct final rule procedures. Elsewhere in this issue of the Federal
Register, FDA is publishing a companion proposed rule under FDA's usual
procedures for notice and comment to provide a procedural framework to
finalize the rule in the event the agency receives a significant
adverse comment and withdraws this direct final rule.
DATES: This rule is effective September 24, 1998. Submit written
comments on or before July 27, 1998. Submit written comments on the
information collection requirements on or before July 13, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Patricia A. Spitzig, Center for
Devices and Radiological Health (HFZ-500), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2812.
SUPPLEMENTARY INFORMATION:
I. Background
Under the act and the Medical Device Amendments of 1976 (the 1976
amendments) (Pub. L. 94-295), FDA issued medical device reporting
regulations for manufacturers on September 14, 1984 (49 FR 36326). To
correct weaknesses noted in the 1976 amendments, and to better protect
the public health by increasing reports of device-related adverse
events, Congress enacted the Safe Medical Devices Act of 1990 (the
SMDA) (Pub. L. 101-629) that required medical device user facilities
and distributors to report certain device-related adverse events.
Distributor reporting requirements became effective on May 28,
1992, following the November 26, 1991 (56 FR 60024), publication of
those provisions in a tentative final rule. In the Federal Register of
September 1, 1993 (58 FR 46514), FDA published a notice announcing that
the proposed distributor reporting regulations had become final by
operation of law and were now codified in part 804 (21 CFR part 804).
On June 16, 1992, the President signed into law the Medical Device
Amendments of 1992 (the 1992 amendments) (Pub. L. 102-112) amending
certain provisions of section 519 of the act (21 U.S.C. 360i) relating
to reporting of adverse device events. Prior to the 1992 amendments,
distributors and manufacturers reported adverse events by using a
``reasonable probability'' standard. Importers may be manufacturers or
distributors, depending on their activities. Among other things, the
1992 amendments amended section 519 of the act to change the reporting
standard for manufacturers and importers; however, the reporting
standard for distributors who are not importers remained the same.
On November 21, 1997, the President signed FDAMA into law. FDAMA
made several changes regarding the reporting of adverse events related
to devices, including the elimination of reporting requirements for
certain distributors, which became effective on February 19, 1998, that
are reflected in this direct final rule. However, section 422 of FDAMA
states that FDA's regulatory authority under the act, relating to
tobacco products, tobacco ingredients, and tobacco additives shall be
exercised under the act as in effect on the day before the date of
enactment of FDAMA. Because the authority relating to tobacco products
remains the same, the reporting requirements for manufacturers and
distributors (including distributors who are importers) of cigarettes
or smokeless tobacco remain unchanged.
Under part 897, the regulations pertaining to tobacco products, and
parts 803 (21 CFR part 803) and 804, the regulations pertaining to
device adverse event reporting, importers may be either manufacturers
or distributors, depending on their activities. Under parts 897, 803,
and 804, importers who repackage or relabel are manufacturers.
Similarly, under those sections, importers whose sole activity is
distribution of devices are defined as distributors.
As previously stated, the 1992 amendments created a bifurcated
reporting standard for distributors, depending on whether they are
domestic distributors or importers. When the agency asserted
jurisdiction over tobacco products and issued regulations under part
897, tobacco distributors also became subject to this bifurcated
reporting standard. Accordingly, the reporting standard applicable to
tobacco products distributors has depended on whether the distributor
is domestic or an importer. Consistent with section 422 of FDAMA, the
direct final rule states that tobacco distributors will continue to use
the appropriate reporting standard as described in Sec. 804.25.
Changes made by FDAMA relating to reporting requirements for all
medical devices other than tobacco products are as follows:
1. Section 213(a) of FDAMA revised section 519(a) of the act to
eliminate distributors as an entity required to report adverse device
events. Importers are still required to report under section 519(a) of
the act.
2. Section 213(a) also amended section 519(a) of the act to clarify
that existing requirements continue to apply for distributors to keep
records concerning adverse device events and make them available to FDA
upon request.
3. Section 213(a)(2) revoked section 519(d) of the act, which
required manufacturers, importers, and distributors to submit to FDA an
annual certification concerning the number of
[[Page 26070]]
reports filed under section 519(a) in the preceding year. As a result,
certification requirements are eliminated.
4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of
the act to require that device user facilities submit an annual rather
than a semiannual summary of their reports to FDA.
5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of
the act. This section had required FDA to disclose, upon request, the
identity of a device user facility making a report under section 519(b)
of the act if the identity of the device user facility was included in
a report required to be submitted by a manufacturer, distributor, or
importer. As a result of this change by FDAMA, FDA may now disclose the
identity of a device user facility only in connection with an action
concerning a failure to report or false or fraudulent reporting, a
communication to the manufacturer of the device, or to the employees of
the Department of Health and Human Services, the Department of Justice,
and duly authorized committees and subcommittees of Congress.
II. Final Rule
A. General Approach
1. To implement these provisions, FDA is amending part 804,
Distributor Reporting, to reflect that the distributor reporting
requirements under that part remain in effect only for distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco, as defined in part 897. FDA is revoking the reporting
requirements under parts 803 and 804 as they apply to distributors who
are not importers of all medical devices other than cigarettes or
smokeless tobacco. FDA is transferring the reporting requirements for
importers of all devices other than cigarettes or smokeless tobacco
from part 804 to part 803, Medical Device Reporting. Importers of
medical devices will continue to be subject to the same reporting and
recordkeeping requirements as they have been under parts 803 and 804,
with the exception that, in accordance with FDAMA, importers of devices
other than cigarettes or smokeless tobacco products are no longer
required to submit annual certifications. They will continue to submit
reports on Form 3500A. FDA will review and revise this form as
necessary in the near future.
2. Distributor recordkeeping requirements, which also remain in
effect, are being transferred from part 804 to part 803, except for
those requirements that apply to distributors of cigarettes or
smokeless tobacco. The recordkeeping requirements for distributors of
cigarettes or smokeless tobacco remain in part 804. No additional
requirements for distributor recordkeeping are being added by these
changes.
3. In accordance with FDAMA, FDA is also amending part 803 to
reflect the change from semiannual to annual reporting for device user
facilities, to eliminate certification requirements for manufacturers
of medical devices other than cigarettes or smokeless tobacco, and to
limit the disclosability of device user facility identities.
4. FDA is not changing or adding any requirements with respect to
manufacturers or distributors of cigarettes or smokeless tobacco, as
defined in part 897.
B. Specific Changes to Parts 803 and 804
Reporting and recordkeeping requirements for distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco, as defined in part 897, remain in part 804. Reporting and
recordkeeping requirements for manufacturers of all medical devices,
including manufacturers of cigarettes or smokeless tobacco, and
importers of devices other than cigarettes or smokeless tobacco are
contained in part 803. Recordkeeping requirements for distributors of
products other than cigarettes or smokeless tobacco are also contained
in part 803. These parts are amended as follows:
Changes to Part 803
1. Section 803.1 is amended to reflect that the scope of the
regulation now includes reporting requirements for importers, as well
as manufacturers and device user facilities, and to clarify that
distributors continue to be responsible for maintaining incident files.
2. Section 803.3 is amended to reflect that importers continue to
be responsible for reporting, by modifying definitions related to
reporting so that importers are included.
3. Section 803.9 is amended by removing paragraph (c)(3), which had
required FDA to disclose the name of a device user facility making a
report if the adverse event was required to be reported by a
manufacturer or distributor. The removal of this paragraph corresponds
to the elimination by FDAMA of section 519(b)(2)(C) of the act.
4. Section 803.10 is amended to reflect that importers of medical
devices remain responsible for reporting adverse device events, by
transferring to this section the requirements that were previously
codified under part 804. Furthermore, Sec. 803.10(a)(2) is amended to
reflect that device user facilities are now responsible for submitting
annual, not semiannual reports. Section 803.10(c)(5) is amended to
correspond with the revocation of section 519(d) of the act, which had
required annual certification of the number of medical devices report
(MDR) reports filed during the preceding year. Revised
Sec. 803.10(c)(5) reflects that manufacturers of cigarettes or
smokeless tobacco continue to be responsible for complying with the
annual certification requirements described in Sec. 803.57.
5. Sections 803.11, 803.17, 803.19, 803.20, 803.22, and 803.56 are
amended to reflect that importers continue to be subject to the MDR
reporting requirements. Section 803.18 is amended to add ``importers''
to reflect that importers continue to be responsible for maintaining
MDR event files, and to clarify that distributors of medical devices
also continue to be responsible for establishing device complaint files
and maintaining device incident records.
6. Section 803.12 is amended to reflect the change from
``semiannual'' to ``annual'' reports, and the continued inclusion of
importers as reporting entities. Section 803.33 is amended to reflect
that device user facilities are required to submit annual, not
semiannual reports.
7. A new subpart D, consisting of Secs. 803.40 and 803.43, has been
added to reflect that importers of medical devices continue to be
subject to the MDR reporting requirements. These sections represent the
transfer of relevant provisions of part 804 (which now applies only to
distributors, including those who are importers, of cigarettes or
smokeless tobacco) into part 803. Importer reporting and recordkeeping
requirements are not being changed by this transfer.
8. Section 803.57 is amended to clarify that the section applies
only to manufacturers of cigarettes or smokeless tobacco. This
amendment reflects the revocation of section 519(d) of the act, which
had required annual certification of the number of MDR reports filed
during the preceding year, as it applied to manufacturers of all
devices other than cigarettes or smokeless tobacco. This change also
reflects the rule of construction in section 422 of FDAMA under which
FDA's regulatory authority under the act relating to tobacco products
shall be exercised under the act as in effect on the day before the
date of enactment of FDAMA.
[[Page 26071]]
Changes to Part 804
1. Section 804.1, the scope of part 804, Medical Device Distributor
Reporting, is amended to reflect that this part now applies only to
distributor reports of adverse events relating to contamination of
cigarettes or smokeless tobacco products.
2. Section 804.3 is amended to limit the definition of
distributors, for the purposes of part 804, to distributors (including
distributors who are importers) of cigarettes or smokeless tobacco
products, and to clarify that adverse events that are reportable by
distributors are only those related to contamination of cigarettes or
smokeless tobacco.
3. Section 804.25 is amended to clarify that adverse events that
are reportable under this part are only those related to contamination
of cigarettes or smokeless tobacco.
III. Rulemaking Action
In the Federal Register of November 21, 1997, FDA described its
procedures on when and how FDA will employ direct final rulemaking. FDA
believes that this rule is appropriate for direct final rulemaking
because FDA views this rule as a noncontroversial amendment and
anticipates no significant adverse comments. Consistent with FDA's
procedures on direct final rulemaking, FDA is publishing elsewhere in
this issue of the Federal Register a companion proposed rule to amend
existing parts 803 and 804. The companion proposed rule and the direct
final rule are substantively identical. The companion proposed rule
provides a procedural framework within which the rule may be finalized
in the event the direct final rule is withdrawn because of a
significant adverse comment. The comment period for the direct final
rule runs concurrently with the companion proposed rule. Any comments
to the companion proposed rule will be considered as comments regarding
the direct final rule.
FDA has provided a comment period on the direct final rule of July
27, 1998. If the agency receives a significant adverse comment, FDA
intends to withdraw this final rule by publication in the Federal
Register within 30 days after the comment period ends. A significant
adverse comment is defined as a comment that explains why the rule
would be inappropriate, including challenges to the rule's underlying
premise or approach, or would be ineffective or unacceptable without
change. In determining whether a significant adverse comment is
sufficient to terminate a direct final rulemaking, FDA will consider
whether the comment raises an issue serious enough to warrant a
substantive response in a notice-and-comment process. Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered significant or adverse under this procedure. For example, a
comment recommending an additional change to the rule may be considered
a significant adverse comment if the comment demonstrates why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can
be severed from the remainder of the rule, FDA may adopt as final those
parts of the rule that are not the subject of a significant adverse
comment.
If FDA withdraws the direct final rule, all comments received will
be considered under the proposed rule in developing a final rule in
accordance with usual Administrative Procedure Act notice-and-comment
procedures.
If FDA receives no significant adverse comment during the specified
comment period, FDA intends to publish a confirmation notice within 30
days after the comment period ends confirming that the direct final
rule will go into effect on September 24, 1998.
IV. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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.
V. Analysis of Impacts
FDA has examined the impact of this direct final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612) (as amended by subtitle D of the Small Business Regulatory
Fairness Act of 1996 (Pub. L. 104-121)), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4). 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 direct
final rule is consistent with the regulatory philosophy and principles
identified in the Executive Order. In addition, this direct final rule
is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The rule codifies the elimination of reporting by
distributors, other than distributors (including distributors who are
importers) of cigarettes or smokeless tobacco, continues reporting by
importers (including distributors who are importers), increases
protection from disclosure of the identity of device user facilities
that have submitted reports, reduces summary reporting by device user
facilities from semiannual to annual, eliminates annual certification
for manufacturers and distributors (including importers) of medical
devices other than cigarettes or smokeless tobacco, and makes other
nonsubstantive changes. The agency certifies that this final rule will
not have a significant economic impact on a substantial number of small
entities. This direct final rule also does not trigger the requirement
for a written statement under section 202(a) of the Unfunded Mandates
Reform Act because it does not impose a mandate that results in an
expenditure of $100 million or more by State, local, or tribal
governments in the aggregate, or by the private sector, in any 1 year.
VI. Paperwork Reduction Act of 1995
This direct final rule contains information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown as follows with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information
[[Page 26072]]
on respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Reporting and recordkeeping requirements for manufacturers,
importers, user facilities, and distributors of medical devices under
FDAMA.
Description: FDAMA contained provisions that affect medical device
reporting in a variety of ways. Section 213 of FDAMA eliminated the
reporting requirements for medical device distributors (but not for
importers), as well as the certification requirements for medical
device manufacturers and distributors. This section of FDAMA also
modified the summary reporting requirements for user facilities to
require annual, rather than semiannual, reporting, and increased
confidentiality of user facility identities. However, section 422 of
FDAMA states that FDA's regulatory authority under the act relating to
tobacco products, tobacco ingredients, and tobacco additives shall be
exercised under the act as in effect on the day before the date of
enactment of FDAMA. Under this rule of construction, the reporting and
certification requirements for manufacturers and distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco remain unchanged.
This rule amends FDA's regulations in parts 803 and 804 to reflect
the changes to medical device reporting made by FDAMA.
This direct final rule eliminates reporting by distributors other
than distributors of cigarettes or smokeless tobacco, continues
reporting by importers, increases the protection from disclosure of the
identity of device user facilities that have submitted reports, reduces
summary reporting by device user facilities from semiannual to annual,
eliminates annual certification for manufacturers and distributors
(including importers) of medical devices other than cigarettes or
smokeless tobacco, and makes other nonsubstantive changes.
Description of Respondents: Businesses or other for profit
organizations.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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No. of
21 CFR Section No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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803.19 150 1 150 3 450
803.33 1,800 1 1,800 1 1,800
803.40 195 1 195 3 585
803.56 750 20 15,000 1 15,000
803.57 31 1 31 1 31
804.25 10 1 10 1.5 15
804.30 1,365 1 1,365 1 1,365
804.32 5 1 5 1 5
804.33 0 0 0 1 0
TOTAL .............. .............. .............. .............. 19,251
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Table 2.--Estimated Annual Recordkeeping Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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803.17 2,000 1 2,000 2 4,000
803.18 39,764 1 39,764 1.5 59,646
804.34 1,365 1 1,365 2 1,365
804.35 1,365 1 1,365 1.5 2,047
TOTAL .............. .............. .............. .............. 67,058
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There are no capital costs or operating and maintenance costs associated with this collection of information.
The burdens under this direct final rule are explained as follows:
Reporting Requirements
Prior to the program change reflected in this rule, Sec. 803.19
allowed manufacturers or user facilities to request an exemption or
variance from the reporting requirements. The agency had estimated that
it would receive approximately 100 such requests annually. Distributors
(including importers) were able to request an exemption or variance
from the reporting requirements under Sec. 804.33. Under this rule,
Sec. 803.19 is modified to transfer the exemption provisions for
importers of medical devices other than cigarettes or smokeless tobacco
from Sec. 804.33 to Sec. 803.19. Furthermore, distributors (who are not
importers) of medical devices other than cigarettes or smokeless
tobacco are no longer required to submit MDR reports under this rule.
The estimated burden for Sec. 803.19 is further adjusted to reflect the
agency's actual experience with this type of submission.
Prior to the program change reflected in this rule, Sec. 803.33
required medical device user facilities to submit summary reports
semiannually. Under this rule, user facilities are required to submit
summary reports annually, thereby significantly decreasing the
reporting burden on user facilities. The estimated burden for this
section is also adjusted to reflect the agency's actual experience with
this type of submission.
Under this rule the reporting requirement for importers of medical
devices other than cigarettes or smokeless tobacco previously codified
under Sec. 804.25 is being transferred to Sec. 803.40. The estimated
burden for importer reporting is based upon the agency's actual
experience with this type of submission. The reporting requirements for
distributors (including distributors who are importers) of cigarettes
or smokeless tobacco have been retained in part 804.
Prior to the program change reflected in this rule, Sec. 803.56
required
[[Page 26073]]
manufacturers to submit supplemental reports containing information not
known or not available at the time the initial report was submitted.
The agency had estimated that it would receive approximately 500 such
requests annually. Distributors (including importers) were required to
submit supplemental information under Sec. 804.32. Under this rule,
Sec. 803.56 is modified to transfer the supplemental reporting
requirements for importers of medical devices other than cigarettes or
smokeless tobacco from Sec. 804.32. Furthermore, distributors (who are
not importers) of medical devices other than cigarettes or smokeless
tobacco are no longer required to submit MDR reports (and thus
supplemental reports as well) under this rule. The estimated burden for
Sec. 803.56 is further adjusted to reflect the agency's actual
experience with this type of submission. The agency also notes that any
additional information requested by the agency in accordance with
Sec. 803.15 is considered to be supplemental information for the
purpose of this information collection and is included in the burden
estimate for Sec. 803.56.
Prior to the program change reflected in this rule, Sec. 803.57
required medical device manufacturers to annually certify as to the
number of reports submitted during the previous year, or that no such
reports had been submitted. Distributors (including importers) were
required to certify under Sec. 804.30. Under this rule, Sec. 803.57 is
modified to require annual certification only for manufacturers of
cigarettes or smokeless tobacco. The certification requirements for
distributors (including distributors who are importers) of cigarettes
or smokeless tobacco have been retained in Sec. 804.30.
Prior to the program change reflected in this rule, Sec. 804.25
required medical device distributors (including importers) to report
adverse device events. Under this rule, distributors of medical devices
other than cigarettes or smokeless tobacco are no longer required to
submit MDR reports, and the reporting requirements for importers of
medical devices other than cigarettes or smokeless tobacco have been
transferred to part 803. Section 804.25 now requires distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco to submit MDR reports for adverse events related to
contamination of their products. The agency believes that there will be
a very small number of MDR reports related to contamination of
cigarettes or smokeless tobacco submitted in any given year.
Prior to the program change reflected in this rule, Sec. 804.30
required medical device distributors (including importers) to certify
as to the number of MDR reports submitted during the previous year, or
that no such reports were submitted. Under this rule, the certification
requirement has been removed for distributors (including importers) of
medical devices other than cigarettes or smokeless tobacco. Section
804.30 now requires distributors (including distributors who are
importers) of cigarettes or smokeless tobacco to submit certifications
of the number of MDR reports submitted for adverse events related to
contamination of their products. The agency has identified 1,365
distributors of cigarettes or smokeless tobacco, each of which shall
submit one certification annually.
Prior to the program change reflected in this rule, Sec. 804.32
required medical device distributors (including importers) to submit
supplemental information related to a previously submitted MDR report.
Under this rule, distributors of medical devices other than cigarettes
or smokeless tobacco are no longer required to submit any MDR reports,
and the reporting requirements for importers of medical devices other
than cigarettes or smokeless tobacco have been transferred to part 803.
Section 804.32 now requires distributors (including distributors who
are importers) of cigarettes or smokeless tobacco to submit
supplemental information related to a previously submitted MDR report.
Because the agency believes that there will be a very small number of
MDR reports submitted in any given year, even fewer supplemental
submissions are anticipated. The agency also notes that any additional
information requested by the agency in accordance with Sec. 804.31 is
considered to be supplemental information for the purpose of this
information collection and is included in the burden estimate for
Sec. 804.32.
Prior to the program change reflected in this rule, Sec. 804.33
allowed medical device distributors (including importers) to request an
exemption or variance from the reporting requirements. Under this rule,
the exemption provisions for importers of medical devices other than
cigarettes or smokeless tobacco are transferred to Sec. 803.19, and
distributors (who are not importers) of medical devices other than
cigarettes or smokeless tobacco are no longer required to submit any
MDR reports under this rule. Section 804.33 now allows distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco to request an exemption or variance from the reporting
requirements. However, because distributors (including distributors who
are importers) of cigarettes or smokeless tobacco are required only to
submit reports of adverse events related to contamination of their
products, the agency does not anticipate any requests for exemptions or
variances from the reporting requirements.
Recordkeeping Requirements
Prior to the program change reflected in this rule, Sec. 803.17
required manufacturers and user facilities to establish written
procedures for employee education, complaint processing, and
documentation of information related to MDR's. Under this rule, the
requirements for establishing written MDR procedures for importers of
medical devices other than cigarettes or smokeless tobacco have been
transferred to Sec. 803.17, and the requirements for distributors
(including importers) of cigarettes or smokeless tobacco are retained
in Sec. 804.34. The agency believes that the majority of manufacturers,
user facilities, and importers have already established written
procedures to document complaints and information related to MDR
reporting as part of their internal quality control system. The agency
has estimated that no more than 2,000 such entities would be required
to establish new procedures, or revise existing procedures, in order to
comply with this provision. For those entities, a one-time burden of 10
hours, annualized over a period of 5 years, is estimated for
establishing written MDR procedures. The remainder of manufacturers,
user facilities, and importers not required to revise their written
procedures to comply with this provision are excluded from the burden
because the recordkeeping activities needed to comply with this
provision are considered ``usual and customary'' under 5 CFR
1320.3(b)(2).
Prior to the program change reflected in this rule, Sec. 803.18
required manufacturers and user facilities to establish and maintain
MDR event files. Distributors (including importers) were required to
establish and maintain MDR event files under Sec. 804.35. Under this
rule, Sec. 803.18 is modified to transfer the recordkeeping
requirements for importers and other distributors of medical devices
other than cigarettes or smokeless tobacco from Sec. 804.35.
Recordkeeping requirements for distributors (including distributors who
are importers) of cigarettes or smokeless tobacco have been retained in
Sec. 804.35.
Prior to the program change reflected in this rule, Sec. 804.34
required distributors (including importers) of all medical devices to
establish written
[[Page 26074]]
procedures for employee education, complaint processing, and
documentation of information related to MDR reports. Under this rule,
distributors of medical devices other than cigarettes or smokeless
tobacco are no longer required to submit MDR reports. Accordingly, they
are no longer subject to the requirement to establish and maintain
written MDR procedures although distributors are required to establish
device complaint files in accordance with 21 CFR 820.198. Under this
rule, the requirement for establishing written MDR procedures for
importers of medical devices other than cigarettes or smokeless tobacco
is transferred to Sec. 803.17, and the requirements for distributors
(including distributors who are importers) of cigarettes or smokeless
tobacco are retained in Sec. 804.34. The agency has estimated a one-
time burden of 10 hours, annualized over a period of 5 years, for
distributors (including distributors who are importers) of cigarettes
or smokeless tobacco to establish written MDR procedures under
Sec. 804.34.
Prior to the program change reflected in this rule, Sec. 804.35
required distributors (including importers) to establish and maintain
MDR event files. Under this rule, the recordkeeping burdens for
distributors (including importers) of medical devices other than
cigarettes or smokeless tobacco have been transferred to Sec. 803.18.
Recordkeeping requirements for distributors (including distributors who
are importers) of cigarettes or smokeless tobacco are retained in
Sec. 804.35.
As provided in 5 CFR 1320.5(c)(1), collections of information in a
direct final rule are subject to the procedures set forth in 5 CFR
1320.10. Interested persons and organizations may submit comments on
the information collection provisions of this direct final rule by July
13, 1998, to the Dockets Management Branch (address above).
At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the direct final rule, FDA will publish a notice in
the Federal Register of OMB's decision to approve, modify, or
disapprove the information collection provisions. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a current valid OMB
control number.
VII. Request for Comments
Interested persons may, on or before July 27, 1998, submit to the
Docket Management Branch (address above) written comments regarding
this rule. The comment period runs concurrently with the comment period
for the companion proposed rule. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday. All comments received
will be considered as comments regarding the companion proposed rule
and this direct final rule. In the event the direct final rule is
withdrawn, all comments received regarding the companion proposed rule
and this direct final rule will be considered comments on the proposed
rule.
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:
PART 803--MEDICAL DEVICE REPORTING
1. The authority citation for 21 CFR part 803 continues to read as
follows:
Authority: 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, device user facilities, importers, and
manufacturers, as defined in Sec. 803.3, must report deaths and serious
injuries to which a device has or may have caused or contributed, must
establish and maintain adverse event files, and must submit to FDA
specified followup and summary reports. Medical device distributors, as
defined in Sec. 803.3, are also required to maintain incident files.
Furthermore, manufacturers and importers are also required to report
certain device malfunctions. 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 803.3 is amended by redesignating paragraphs (m) through
(ee) as paragraphs (n) through (ff), respectively; by revising the last
sentence of the introductory text of paragraph (c), paragraph (c)(1),
and redesignated paragraphs (p), (p)(1), and (r)(2); and by adding
paragraphs (g) and (m) to read as follows:
Sec. 803.3 Definitions.
* * * * *
(c) * * * Manufacturers and importers are considered to have become
aware of an event when:
(1) Any employee becomes aware of a reportable event that is
required to be reported by an importer within 10 days, or by a
manufacturer within 30 days or within 5 days under a written request
from FDA under Sec. 803.53(b); and
* * * * *
(g) Distributor means, for the purposes of this part, any person
(other than the manufacturer or importer) who furthers the marketing of
a device from the original place of manufacture to the person who makes
final delivery or sale to the ultimate user, but who does not repackage
or otherwise change the container, wrapper or labeling of the device or
device package. One who repackages or otherwise changes the container,
wrapper, or labeling, is a manufacturer under Sec. 803.3(o). For the
purposes of this part, distributors do not include distributors of
cigarettes or smokeless tobacco.
* * * * *
(m) Importer means, for the purposes of this part, any person who
imports a device into the United States and who furthers the marketing
of a device from the original place of manufacture to the person who
makes final delivery or sale to the ultimate user, but who does not
repackage or otherwise change the container, wrapper, or labeling of
the device or device package. One who repackages or otherwise changes
the container, wrapper, or labeling, is a manufacturer under
Sec. 803.3(o). For the purposes of this part, importers do not include
importers of cigarettes or smokeless tobacco.
* * * * *
(p) Manufacturer or importer report number means the number that
uniquely identifies each individual adverse event report submitted by a
manufacturer or importer. This number consists of three parts as
follows:
(1) The FDA registration number for the manufacturing site of the
reported device, or for the importer. (If the
[[Page 26075]]
manufacturing site or the importer does not have a registration number,
FDA will assign a temporary number until the site is officially
registered. The manufacturer or importer will be informed of the
temporary number.);
* * * * *
(r) * * *
(2) An event about which manufacturers or importers have received
or become aware of information that reasonably suggests that one of
their marketed devices:
(i) May have caused or contributed to a death or serious injury; or
(ii) Has malfunctioned and that the device or a similar device
marketed by the manufacturer or importer would be likely to cause a
death or serious injury if the malfunction were to recur.
* * * * *
Sec. 803.9 [Amended]
4. Section 803.9 Public availability of reports is amended by
adding ``or'' after the semicolon at the end of paragraph (c)(2), by
removing paragraph (c)(3), and by redesignating paragraph (c)(4) as
paragraph (c)(3).
5. Section 803.10 is amended by revising the heading and paragraphs
(a)(2) and (c)(5), and by adding paragraph (b) to read as follows:
Sec. 803.10 General description of reports required from user
facilities, importers, and manufacturers.
(a) * * *
(2) User facilities must submit annual reports as described in
Sec. 803.33.
(b) Importers must submit MDR reports of individual adverse events
within 10 working days after the importer becomes aware of an MDR
reportable event as described in Sec. 803.3. Importers must submit
reports of device-related deaths or serious injuries to FDA and the
manufacturer and reports of malfunctions to the manufacturer.
(c) * * *
(5) For manufacturers of cigarettes or smokeless tobacco, annual
certification to FDA of the number of MDR reports filed during the
preceding year as described in Sec. 803.57.
Sec. 803.11 [Amended]
6. Section 803.11 Obtaining the forms is amended in the first
sentence by adding the word
``, importers,'' after the phrase ``User facilities''.
7. Section 803.12 is amended by revising paragraph (b) to read as
follows:
Sec. 803.12 Where to submit reports.
* * * * *
(b) Each report and its envelope shall be specifically identified,
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,''
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
Sec. 803.17 [Amended]
8. Section 803.17 Written MDR procedures is amended in the
introductory paragraph by adding the word ``, importers,'' after the
phrase ``User facilities''.
9. Section 803.18 is amended by revising the heading, the first
sentence of paragraphs (a) and (b)(1) introductory text, paragraphs
(b)(1)(ii) and (b)(2), and the second sentence of paragraph (c), and by
adding paragraph (d) to read as follows:
Sec. 803.18 Files and distributor records.
(a) User facilities, importers, and manufacturers shall establish
and maintain MDR event files. * * *
(b)(1) For purposes of this part, ``MDR event files'' are written
or electronic files maintained by user facilities, importers, and
manufacturers. * * *
(ii) Copies of all MDR forms, as required by this part, and other
information related to the event that was submitted to FDA and other
entities (e.g., an importer, distributor, or manufacturer).
(2) User facilities, importers, and manufacturers shall permit any
authorized FDA employee during all reasonable times to access, to copy,
and to verify the records required by this part.
(c) * * * Manufacturers and importers shall retain an MDR event
file relating to an adverse event for a period of 2 years from the date
of the event or a period of time equivalent to the expected life of the
device, whichever is greater. * * *
(d)(1) A device distributor shall establish device complaint files
in accordance with Sec. 820.198 of this chapter and maintain an
incident record containing any information, including any written or
oral communication, that alleges deficiencies related to the identity,
quality, durability, reliability, safety, effectiveness, or performance
of a device. Device incident records shall be prominently identified as
such and shall be filed by device.
(2) A device distributor shall retain copies of the records
required to be maintained under this section for a period of 2 years
from the date of inclusion of the record in the file or for a period of
time equivalent to the design and expected life of the device,
whichever is greater, even if the distributor has ceased to distribute
the device that is the subject of the record.
(3) A device distributor shall maintain the device complaint files
established under this section at the distributor's principal business
establishment. A distributor that is also a manufacturer may maintain
the file at the same location as the manufacturer maintains its
complaint file under Secs. 820.180 and 820.198 of this chapter. A
device distributor shall permit any authorized FDA employee, during all
reasonable times, to have access to, and to copy and verify, the
records required by this part.
Sec. 803.19 [Amended]
10. Section 803.19 Exemptions, variances, and alternative reporting
requirements is amended by adding in paragraphs (b) and (c) the word
``, importers,'' before the phrase ``or user facility,'' and by adding
in paragraph (c) a comma after the word ``variance''.
11. Section 803.20 is amended by revising the last sentence of
introductory text of paragraph (a), paragraph (a)(1), and the first
sentence of paragraph (a)(2), and by adding paragraph (b)(2) to read as
follows:
Sec. 803.20 How to report.
(a) * * * The form has sections that must be completed by all
reporters and other sections that must be completed only by the user
facility, importer, or manufacturer.
(1) The front of FDA Form 3500A is to be filled out by all
reporters. The front of the form requests information regarding the
patient, the event, the device, and the ``initial reporter'' (i.e., the
first person or entity that submitted the information to the user
facility, manufacturer, or importer).
(2) The back part of the form contains sections to be completed by
user facilities, importers, and manufacturers. * * *
(b) * * *
(2) Importers are required to submit MDR reports to FDA and the
device manufacturer, except for malfunctions which are reported to the
manufacturer only:
(i) Within 10 working days of becoming aware of information that
reasonably suggests that a device has or may have caused or contributed
to a death or serious injury.
(ii) Within 10 working days of receiving information that a device
marketed by the importer has malfunctioned and that such a device or a
similar device marketed by the importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.
* * * * *
[[Page 26076]]
Sec. 803.22 [Amended]
12. Section 803.22 When not to file is amended by adding in
paragraphs (a) and (b)(1) the word ``, importer,'' after the word
``facility''.
Sec. 803.33 [Amended]
13. Section 803.33 Semiannual reports is amended by revising the
heading to read ``Annual reports''; in introductory text of paragraph
(a) by removing the phrase ``(for reports made July through December)
and by July 1 (for reports made January through June)''; in
introductory text of paragraph (a) and paragraphs (a)(5), (a)(7)
introductory text, and (c) by removing the word ``semiannual'' wherever
it appears and adding in its place the word ``annual''; in paragraph
(a)(2) by removing the phrase ``and period, e.g., January through June
or July through December''; and by adding in paragraph (a)(7)(vi) the
word ``importer,'' after the word ``distributor,''.
14. Subpart D, consisting of Secs. 803.40 and 803.43, is added to
read as follows:
Subpart D--Importer Reporting Requirements
Sec.
803.40 Individual adverse event reporting requirements; importers.
803.43 Individual adverse event report data elements.
Subpart D--Importer Reporting Requirements
Sec. 803.40 Individual adverse event reporting requirements;
importers.
(a) An importer shall submit to FDA a report, and a copy of such
report to the manufacturer, containing the information required by
Sec. 803.43 on FDA form 3500A as soon as practicable, but not later
than 10 working days after the importer receives or otherwise becomes
aware of information from any source, including user facilities,
individuals, or medical or scientific literature, whether published or
unpublished, that reasonably suggests that one of its marketed devices
may have caused or contributed to a death or serious injury.
(b) An importer shall submit to the manufacturer a report
containing information required by Sec. 803.43 on FDA form 3500A, as
soon as practicable, but not later than 10 working days after the
importer receives or otherwise becomes aware of information from any
source, including user facilities, individuals, or through the
importer's own research, testing, evaluation, servicing, or maintenance
of one of its devices, that one of the devices marketed by the importer
has malfunctioned and that such device or a similar device marketed by
the importer would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur.
Sec. 803.43 Individual adverse event report data elements.
(a) Each importer that submits a report on an MDR reportable event
shall complete and submit the applicable portions of FDA form 3500A in
so far as the information is known or should be known to the importer,
and submit it to FDA, and to the manufacturer as required by
Sec. 803.40.
(b) Each importer shall submit the information requested on FDA
form 3500A, including:
(1) Identification of the source of the report.
(i) Type of source that reported the event to the importer (e.g.,
lay user owner, lay user lessee, hospital, nursing home, outpatient
diagnostic facility, outpatient treatment facility, ambulatory surgical
facility);
(ii) Importer report number;
(iii) Name, address, and telephone number of the source that
reported the event to the importer (e.g., distributor, user facility,
practitioner, etc.); and
(iv) Name of the manufacturer of the device.
(2) Date information.
(i) The date of the occurrence of the event;
(ii) The date the source that reported the event to the importer
became aware of the event;
(iii) The date the event was reported to the manufacturer and/or
FDA; and
(iv) The date of this report.
(3) The type of MDR reportable event (e.g., death, serious illness,
serious injury, or malfunction), and whether an imminent hazard was
involved;
(4) Patient information including age, sex, diagnosis, and medical
status immediately prior to the event and after the event;
(5) Device information including brand and labeled name, generic
name, model number or catalog number or other identifying numbers,
serial number or lot number, purchase date, expected shelf life/
expiration date (if applicable), whether the device was labeled for
single use, and date of implant (if applicable);
(6) Maintenance/service information data including the last date of
service performed on the device, where service was performed, whether
service documentation is available, and whether service was in
accordance with the service schedule;
(7) Whether the device is available for evaluation and, if not, the
disposition of the device;
(8) Description of the event, including:
(i) Who was operating or using the device when the event occurred;
(ii) Whether the device was being used as labeled or as otherwise
intended;
(iii) The location of the event;
(iv) Whether there was multi-patient involvement, and if so, how
many patients were involved;
(v) A list of any other devices whose performance may have
contributed to the event and their manufacturers, and the results of
any analysis or evaluation with respect to such device (or a statement
of why no analysis or evaluation was performed); and
(vi) A complete description of the event including, but not limited
to, what happened, how the device was involved, the nature of the
problem, patient followup/treatment required, and any environmental
conditions that may have influenced the event.
(9) The results of any analysis of the device and the event,
including:
(i) The method of the evaluation or an explanation of why no
evaluation was necessary or possible;
(ii) The results and conclusions of the evaluation;
(iii) The corrective actions taken; and
(iv) The degree of certainty concerning whether the device caused
or contributed to the reported event;
(10) The name, title, address, telephone number, and signature of
the person who prepared the report.
Sec. 803.56 [Amended]
15. Section 803.56 Supplemental reports is amended in the
introductory paragraph and in paragraphs (a) and (b) by adding the
words ``or importer'' after the word ``manufacturer''.
Sec. 803.57 [Amended]
16 Section 803.57 Annual certification is amended in paragraphs (a)
and (d) by removing the word ``manufacturers'' wherever it appears and
by adding in its place the phrase ``manufacturers of cigarettes or
smokeless tobacco'', and in paragraphs (b), (c)(1), and (d) by removing
the word ``manufacturer'' wherever it appears and adding in its place
the phrase ``manufacturer of cigarettes or smokeless tobacco''.
PART 804--MEDICAL DEVICE REPORTING FOR DISTRIBUTORS OF CIGARETTES
OR SMOKELESS TOBACCO
17. The authority citation for 21 CFR part 804 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
[[Page 26077]]
18. Part 804 is amended by revising the heading to read as set
forth above.
19. Section 804.1 is amended by revising paragraph (a) to read as
follows:
Sec. 804.1 Scope.
(a) FDA is requiring distributors of cigarettes or smokeless
tobacco to report deaths, serious illnesses, and serious injuries that
are attributed to contamination of a cigarette or smokeless tobacco
product. Distributors of cigarettes or smokeless tobacco are also
required to submit a report to FDA annually certifying the number of
medical device reports filed during the preceding year, or that no
reports were filed. These reports enable FDA to protect the public
health by helping to ensure that these products are not adulterated or
misbranded and are otherwise safe and effective for their intended use.
In addition, distributors of cigarettes or smokeless tobacco are
required to establish and maintain complaint files or incident files as
described in Sec. 804.35, and to permit any authorized FDA employee at
all reasonable times to have access to, and to copy and verify, the
records contained in this file. This part supplements, and does not
supersede, other provisions of this subchapter, including the
provisions of part 820 of this chapter.
* * * * *
20. Section 804.3 is amended by revising paragraph (d), and in
paragraphs (m)(1) and (m)(2) by adding the phrase ``related to the
contamination of cigarettes or smokeless tobacco'' after the word
``event'' to read as follows:
Sec. 804.3 Definitions.
* * * * *
(d) Distributor means, for the purpose of this part, any person who
furthers the distribution of cigarettes or smokeless tobacco, whether
domestic or imported, at any point from the original place of
manufacture to the person who sells or distributes the product to
individuals for personal consumption, but who does not repackage or
otherwise change the container, wrapper, or labeling of the product
package. Common carriers are not considered distributors for the
purposes of this part.
* * * * *
Sec. 804.25 [Amended]
21. Section 804.25 Reports by distributors is amended in paragraph
(a)(1) by removing the words ``a device'' and adding in their place the
phrase ``contamination of a cigarette or smokeless tobacco product'';
in paragraph (a)(2) by removing the phrase ``one of its marketed
devices'' and adding in its place the phrase ``contamination of one of
its cigarette or smokeless tobacco products''; and by removing
paragraph (c).
Dated: May 1, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12614 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F
