[Federal Register: January 26, 2000 (Volume 65, Number 17)]
[Notices]
[Page 4249-4252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja00-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0595]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Reporting and Recordkeeping Requirements for
Manufacturers, Importers, User Facilities, and Distributors of Medical
Devices Under FDAMA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
February 26, 2000.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has
[[Page 4250]]
submitted the following proposed collection of information to OMB for
review and clearance.
Reporting and Recordkeeping Requirements for Manufacturers,
Importers, User Facilities, and Distributors of Medical Devices
Under FDAMA
Description: The Food and Drug Administration Modernization Act of
1997 (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.
The final rule published elsewhere in this issue of the Federal
Register amends FDA's regulations in part 803 (21 CFR part 803) and
revokes part 804 (21 CFR part 804) to reflect the changes to medical
device reporting made by FDAMA. The final rule has also been amended to
implement the exemptions for manufacturers and distributors of
cigarettes and smokeless tobacco products discussed in the next
paragraphs.
In accordance with 5 CFR 1320.8(d), requests for public comment
were published in the Federal Register of May 12, 1998 (63 FR 26069 and
63 FR 26129). Several comments were received in response to the
proposed rule. A detailed discussion of the comments and FDA's response
is included in the preamble to the final rule published elsewhere in
this issue of the Federal Register.
Four comments objected that FDA did not follow the congressional
recommendation in the conference report on FDAMA that FDA limit the
time that distributors be required to keep records to a maximum of 6
years. The direct final rule required that distributors keep records
for 2 years or the expected life of the device, whichever is greater.
FDA carefully considered the recommendations of the conference
committee. The agency determined that the protection of the public
health would not be adequately served if distributor recordkeeping was
limited to a period of 6 years. Under the new quality system
regulations contained in part 820 (21 CFR part 820), manufacturers
(including initial distributors of foreign manufacturers) must retain
records for a period equal to the design and expected life of the
device (but no less than 2 years). The agency believes it is
appropriate to require distributors to retain records for the same time
period. This is especially important because distributors are no longer
required to report any adverse event information to the agency, and the
agency's primary access to the distributor complaint information is its
periodic inspection and examination of the distributor records.
FDA considered electronic retention of distributor records. Prior
to FDAMA and the proposed rule, the agency had not prohibited the
electronic retention of records, nor did it intend to prohibit
electronic recordkeeping based upon the proposal. When the distributor
recordkeeping requirements were shifted from part 804 to part 803, the
language remained largely unchanged. However, in order to avoid further
confusion regarding electronic retention of records, the agency is
modifying proposed Sec. 803.18(d)(1) to clarify that distributor
records may be either written or electronic.
Three comments stated that it is inappropriate to refer to the
quality systems regulation (Sec. 820.198) in describing distributor
recordkeeping because Sec. 820.198 does not apply to distributors.
FDA agrees and has revised Sec. 803.18(d) accordingly to remove the
reference to Sec. 820.198. FDA is substituting language to identify the
relevant requirements from Sec. 820.198 that apply to distributors who
are not importers. However, FDA notes that Sec. 820.198 does apply to
importers of devices.
Two comments suggested that the reporting timeframe for importers
should be changed to from 10 days to 30 days.
FDA agrees with these comments and has revised the final rule.
Previously, importers were included in part 804 with the reporting
requirements for distributors. Because distributors are no longer
required to report, part 804 is eliminated and importers are included
in part 803 with manufacturers. The 30-day timeframe is consistent with
the timeframe for manufacturers.
One comment suggested that the form for reporting adverse events
(FDA Form 3500A) should be revised to refer specifically to importers.
Another comment asked for clarification as to whether a person who
sells directly to the ultimate user may be considered an ``importer.''
The agency agrees that the fields to be filled out by importers on
FDA Form 3500A should be specified within the regulation. Because the
requirements and burdens would not be affected by revising the style
and format of Sec. 803.43, the agency is modifying the section to be
consistent with Secs. 803.32 and 803.52, which describe the information
to be submitted on the MEDWATCH form. Proposed Sec. 803.43 will be
redesignated as Sec. 803.42 in the final rule.
The agency notes that, because ``distributors'' had previously been
defined to include ``importers,'' FDA Form 3500A does not specifically
address importer information and does not use the term, ``importers.''
However, block F of the MEDWATCH form is identified for use by device
user facilities and distributors. An importer should continue to
complete blocks A, B, D, E, and F until the form is revised to remove
references to ``distributor'' and replace them with ``importer.'' The
agency clarifies that firms who purchase products from a foreign
manufacturer and sell directly to the ultimate user are considered
retailers and not importers under part 803, and they are not required
to report.
One comment suggested that distributor reporting is important for
the protection of the public health and recommended that, as an
alternative to distributor reporting, FDA should require manufacturer
contact information on the labeling to ensure proper adverse event
reporting.
The agency agrees that consumers are likely to contact medical
device distributors with their device complaints. Without distributor
reporting, it is possible that the agency will not receive information
regarding some complaints. However, under FDAMA, the agency no longer
has the authority to require distributor reporting. Although FDA cannot
require distributor reporting, FDA encourages distributors to report
adverse event information to manufacturers so that they may investigate
and report it as appropriate. The suggestion that FDA require
manufacturer contact information on the labeling is beyond the scope of
this rule and FDA will consider it separately.
One comment objected that FDA incorrectly interpreted section 422
of FDAMA regarding the regulation of tobacco products, tobacco
ingredients, and tobacco additives. The comment stated that section 422
of FDAMA only means that nothing in FDAMA shall affect whether FDA has
the authority to regulate tobacco products. The comment further said
that section 422 of FDAMA does not mean, as FDA believes, that the
requirements, such as medical device report (MDR) reporting, for
manufacturers and distributors of
[[Page 4251]]
tobacco products are unchanged by FDAMA.
The agency disagrees with this comment. Section 422 of FDAMA states
that ``Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health and
Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive.'' Although this language may
suggest that FDAMA is simply silent regarding the agency's authority to
regulate tobacco, section 422 goes on to state that ``Such authority,
if any, shall be exercised under the Federal Food, Drug, and Cosmetic
Act as in effect on the day before the date of the enactment of this
act.'' Beyond the question of whether the agency has authority to
regulate tobacco, this language directs the agency as to how it should
exercise such authority once pending litigation is resolved.
Under section 422 of FDAMA, therefore, Congress neither affirms nor
denies the agency's authority to regulate tobacco, but it does direct
the agency to continue regulating tobacco as it had been doing prior to
FDAMA (if authority to regulate tobacco exists). Prior to FDAMA,
distributor reporting and manufacturer and distributor certification
were required under the Federal Food, Drug, and Cosmetic Act (the act).
If the agency were to exercise its authority under the act ``as in
effect on the day before the date of the enactment of [FDAMA],''
distributor reporting and manufacturer and distributor certification
requirements would continue to apply to manufacturers and distributors
of cigarettes and smokeless tobacco products.
However, while the agency disagrees with the comment's
interpretation of section 422 of FDAMA, FDA finds persuasive the
comment's arguments that tobacco manufacturers should be exempt from
the requirement of annual certification of MDR's and that distributors
should be exempt from MDR reporting requirements under the residual
authority of the act. The agency has authority under section 519(c) of
the act (21 U.S.C. 360i(c)) to exempt, by regulation, any person from
the medical device reporting requirements upon a finding that such
reporting is not necessary to ``assure that a device is not adulterated
or misbranded or * * * otherwise to assure its safety and
effectiveness.'' The agency finds that the statutory criteria for
exemption are met in light of the fact that Congress has repealed the
requirements for manufacturer and distributor annual certification and
distributor reporting. A reasonable assurance of the safety and
effectiveness of tobacco products will be provided by the remaining
medical device reporting requirements, that is, reporting and
recordkeeping required of manufacturers and importers and recordkeeping
required of distributors.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden 1
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Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
respondents response responses response
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803.15 50 1 50 4 200
803.19 150 1 150 3 450
803.22(b)(2) 100 1 100 0.25 25
803.33 (FDA Form 3419) 1,800 1 1,800 1 1,800
803.40 195 1 195 3 585
803.55 (FDA Form 3417) 1,000 20 20,000 1.1 22,000
Total 25,060
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden1
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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 3.3 6,600
803.18 39,764 1 39,764 1.5 59,646
Total 66,246
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burdens under the direct final rule (63 FR 26069) are explained
in the following paragraphs.
I. Reporting Requirements
Prior to the program change reflected in this rule, distributors
(including importers) were required to submit supplemental information
under Sec. 804.32. Distributors (who are not importers) are no longer
required to submit MDR reports (including supplemental reports), and
FDA has determined that it will not be necessary for importers to
submit supplemental information except when FDA requests additional
information under Sec. 803.15. FDA has revised the final rule
accordingly. Section 803.15 provides that FDA may request a reporter to
submit additional or clarifying information concerning an MDR report
when FDA determines that additional information is necessary for the
protection of the public health. The burden estimate for Sec. 803.15
includes only the burden for importers.
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 from Sec. 804.33 to Sec. 803.19.
Furthermore, distributors (who are not importers) of medical devices
are no longer required to submit MDR reports under this rule.
[[Page 4252]]
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. 803.22(b)(2) provided that, if a manufacturer erroneously receives
information about an adverse event concerning a device that they had
not manufactured, the manufacturer must submit the report to FDA along
with a cover letter explaining that the device in question was not
manufactured by that firm. This final rule amends Sec. 803.22(b)(2) to
apply the same requirement to importers. The requirements of
Sec. 803.22(b)(2) were not previously reviewed by OMB under the PRA.
Thus, the estimated burden reflects FDA's experience with this
provision with regard to manufacturers and includes the estimated
burden for both manufacturers and importers.
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. FDA Form 3419 is being revised to reflect this
change.
Under this rule the reporting requirement for importers of medical
devices 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. Section
803.40 requires importers to submit reports within 30 days after
learning of the reportable event rather than 10 days as provided in
Sec. 804.25; this change does not affect the burden.
This rule does not amend Sec. 803.55, but FDA is seeking approval
for FDA Form 3417 on which baseline reports are to be submitted. The
agency's estimate is based on FDA's actual experience with this type of
submission.
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. As stated previously, FDA is
also exempting manufacturers and distributors of cigarettes and
smokeless tobacco products from the requirement of annual
certification. Therefore, under this rule, Secs. 803.57 and 804.30 are
being eliminated.
Because distributors, including distributors of cigarettes and
smokeless tobacco products, will no longer be required to report, the
final rule also removes Secs. 804.25 (distributor reporting), 804.32
(supplemental information), and 804.33 (alternative reporting
requirements).
II. 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 have been transferred to Sec. 803.17. 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,
including cigarettes and smokeless tobacco products from Sec. 804.35;
therefore, Sec. 804.35 is removed. As discussed previously, this
recordkeeping may be done in an electronic format.
Under the proposed rule, distributors of cigarettes and smokeless
tobacco products would have been required to establish written internal
procedures for evaluating and reporting events. Because distributors of
cigarettes and smokeless tobacco products will not be required to
report under the final rule, Sec. 804.34 is removed.
Dated: January 18, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-1786 Filed 1-25-00; 8:45 am]
BILLING CODE 4160-01-F