[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Proposed Rules]
[Pages 26129-26137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12610]
-----------------------------------------------------------------------
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;
Companion Document to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
certain regulations governing reporting by manufacturers, importers,
distributors, and health care (user) facilities of adverse events
related to medical devices. This proposed rule is a companion document
to the direct final rule, published elsewhere in this issue of the
Federal Register. The amendments are intended to implement provisions
of 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 this 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 the direct final rule.
DATES: 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 on the proposed rule 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: This proposed rule is a companion to the
direct final rule published in the final rules section of this issue of
the Federal Register. This companion proposed rule is substantively
identical to the direct final rule. This proposed rule will provide a
procedural framework to finalize the rule in the event the agency
receives a significant adverse comment and the direct final rule is
withdrawn. FDA is publishing the direct final rule
[[Page 26130]]
because the rule contains noncontroversial changes, and FDA anticipates
that it will receive no significant adverse comments. A detailed
discussion of this rule is set forth in the preamble of the direct
final rule. If no significant comment is received in response to the
direct final rule, no further action will be taken related to this
proposed rule. Instead, FDA will 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. Additional information
about FDA's direct final rulemaking procedures is set forth in a
guidance published in the Federal Register of November 21, 1997 (62 FR
62466).
If FDA receives a significant adverse comment regarding this rule,
the agency will publish a document withdrawing the direct final rule
within 30 days after the comment period ends and will proceed to
respond to the comments under this rule using usual notice-and-comment
procedures. The comment period for this companion proposed rule runs
concurrently with the direct final rule's comment period. Any comments
received under this companion proposed rule will also be considered as
comments regarding the direct final rule. 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 a 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
adverse under this procedure. For example, a comment recommending a
rule change in addition to the rule will not be considered a
significant adverse comment, unless the comment states 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.
This action is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiative,
and is intended to reduce the burden of unnecessary regulations on
medical devices without diminishing the protection of public health.
I. Background
Under the act and the Medical Device Amendments of 1976 (Pub. L.
94-295) (the 1976 amendments), 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 (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, publication of those provisions
in a tentative final rule (56 FR 60024). 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 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 proposed 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 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
proposed 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 to 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 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
[[Page 26131]]
disclose, upon request, the identity of a user facility making a report
under section 519(b), if the identity of the user facility was included
in a report submitted by a manufacturer, distributor, or importer. As a
result of this change by FDAMA, FDA may now disclose the identity of a
user facility only in connection with an action concerning a failure to
report or false or fraudulent reporting, in 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.
To implement these provisions, FDA is issuing this proposed rule. A
summary of the rule is contained in the preamble to the direct final
rule published elsewhere in this issue of the Federal Register.
II. 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.
III. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866, 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 proposed rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, this proposed 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 proposed rule would eliminate reporting by
distributors, other than distributors (including distributors who are
importers) of cigarettes or smokeless tobacco, continue reporting by
importers (including distributors who are importers), increase
protections from disclosure of the identity of device user facilities
that have submitted reports, reduce summary reporting by device user
facilities from semiannual to annual, eliminate annual certification
for manufacturers and distributors (including importers) of medical
devices other than cigarettes or smokeless tobacco, and make other
nonsubstantive changes. The agency certifies that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. This proposed 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.
IV. Paperwork Reduction Act of 1995
This proposed 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 the 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
proper 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 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 modified the
summary reporting requirements for user facilities to require annual,
rather than semiannual, reporting, and increased confidentiality of
user facility identities. This section of FDAMA also eliminated the
reporting requirements for medical device distributors (but not for
importers), as well as the certification requirements for medical
device manufacturers and distributors. 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 proposed rule would amend FDA's regulations in 21 CFR Parts
803 and 804 to reflect the changes to medical device reporting made by
FDAMA.
This proposed rule would eliminate reporting by distributors other
than distributors of cigarettes or smokeless tobacco, continue
reporting by importers, increase the protection from disclosure of the
identity of device user facilities that have submitted reports, reduce
summary reporting by device user facilities from semiannual to annual,
eliminate annual certification for manufacturers and distributors
(including importers) of medical devices other than cigarettes or
smokeless tobacco, and make other nonsubstantive changes.
Description of Respondents: Businesses or other for profit
organizations.
FDA estimates the burden for this collection of information as
follows:
[[Page 26132]]
Table 1.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR No. of Responses per
Section No. of Respondents Respondent Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Annual Frequency per
Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 1 1,365
804.35 1,365 1 1,365 1.5 2,047
Total .......................... .......................... .......................... .......................... 67,058
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: There are no operating and maintainance cost or capital costs associated with this collection of information.
The burdens under this proposed rule are explained as follows:
A. Reporting Requirements
Prior to the program change proposed 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 proposed
rule, Sec. 803.19 would be 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 would no longer be required to submit
MDR reports under this proposed 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 proposed in this rule, Sec. 803.33
required medical device user facilities to submit summary reports
semiannually. Under this proposed rule, user facilities would be
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 proposed rule the reporting requirement for importers of
medical devices other than cigarettes or smokeless tobacco previously
codified under Sec. 804.25 would be transferred to new proposed
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 would be retained in part
804.
Prior to the program change proposed in this rule, Sec. 803.56
required 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
distributors who are importers) were required to submit supplemental
information under Sec. 804.32. Under this proposed rule, Sec. 803.56
would be 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 would no longer be required to submit MDR reports (and thus
supplemental reports as well) under this proposed 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 proposed 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 proposed rule,
Sec. 803.57 would be 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 would be retained in
Sec. 804.30.
Prior to the program change proposed in this rule, Sec. 804.25
required medical device distributors (including importers) to report
adverse device events. Under this proposed 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 would be transferred to part 803. Section 804.25 would require
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
[[Page 26133]]
of cigarettes or smokeless tobacco submitted in any given year.
Prior to the program change proposed 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 distributors
who are importers) of medical devices other than cigarettes or
smokeless tobacco. Section 804.30 now would require 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 would submit one certification annually.
Prior to the program change proposed 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 proposed 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 would be transferred
to part 803. Section 804.32 would require 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 related to contamination of cigarettes or
smokeless tobacco 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 section 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 proposed 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 would be 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 would allow 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.
B. Recordkeeping Requirements
Prior to the program change proposed 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 proposed
rule, the requirement for establishing written MDR procedures for
importers of medical devices other than cigarettes or smokeless tobacco
would be transferred to Sec. 803.17, and the requirements for
distributors (including importers) of medical devices other than
cigarettes of smokeless tobacco would be 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 proposed 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
proposed rule, Sec. 803.18 would be 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
would be retained in Sec. 804.35.
Prior to the program change proposed in this rule, Sec. 804.34
required distributors (including importers) of all medical devices to
establish written procedures for employee education, complaint
processing and documentation of information related to MDR reports.
Under this proposed rule, distributors of medical devices other than
cigarettes or smokeless tobacco would no longer be required to submit
MDR reports although distributors are required to establish device
complaint files in accordance with 21 CFR 820.198. Accordingly, they
would no longer be subject to the requirement to establish and maintain
written MDR procedures. Under the proposed rule, the requirement for
establishing written MDR procedures for importers of medical devices
other than cigarettes or smokeless tobacco would be transferred to
Sec. 803.17, and the requirements for distributors (including
distributors who are importers) of cigarettes or smokeless tobacco
would be 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 proposed in this rule, Sec. 804.35
required distributors (including importers) to establish and maintain
MDR event files. Under this proposed rule, the recordkeeping burdens
for distributors (including importers) of medical devices other than
cigarettes or smokeless tobacco would be transferred to Sec. 803.18.
Recordkeeping requirements for distributors (including distributors who
are importers) of cigarettes or smokeless tobacco would be retained in
Sec. 804.35.
For consistency with the direct final rule to which this proposed
rule is a companion, FDA is following the Paperwork Reduction Act
comment procedures for direct final rules in this proposed rule. 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 proposed rule July 13, 1998
to the Dockets Management Branch (address above).
[[Page 26134]]
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 currently valid OMB
control number.
V. Request for Comments
Interested persons may, on or before July 27, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this companion proposed rule. The comment period runs concurrently with
the comment period for the direct final 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 the
brackets in the heading of this document. Comments will be considered
to determine whether to amend or revoke this proposed rule. 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 direct final rule and this proposed rule. In the
event the direct final rule is withdrawn, all comments received
regarding the direct final rule and this companion proposed rule will
be considered comments on this 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, it is
proposed that 21 CFR parts 803 and 804 be 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 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.
[[Page 26135]]
(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.
* * * * *
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
[[Page 26136]]
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.
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,
[[Page 26137]]
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. 98-12610 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F
