[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Notices]
[Pages 4249-4252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1786]


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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