[Federal Register Volume 68, Number 6 (Thursday, January 9, 2003)]
[Notices]
[Pages 1187-1188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-361]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0405]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Medical Device Reporting: Manufacturer 
Reporting, Importer Reporting, User Facility Reporting, and Distributor 
Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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.

DATES: Submit written comments on the collection of information by 
February 10, 2003.

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: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Reporting: Manufacturer Reporting, Importer Reporting, 
User Facility Reporting, and Distributor Reporting (OMB Control Number 
0910-0437)--Extension

    Section 519(a), (b), and (c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360i (a), (b), and (c)) requires user 
facilities, manufacturers, and importers of medical devices to report 
adverse events involving medical devices to FDA. On December 11, 1995 
(60 FR 63578 at 63597), FDA issued part 803 (21 CFR part 803) that 
implemented section 519 of the act. The regulation was amended to 
conform with the changes reflected in the 1997 FDA Modernization Act.
    Information from these reports will be used to evaluate risks 
associated with medical devices and to enable FDA to take appropriate 
regulatory measures to protect the public health.
    Respondents to this collection of information are businesses or 
other for profit and non-profit organizations including user 
facilities, manufacturers, and importers of medical devices.
    In the Federal Register of Tuesday, October 1, 2002 (67 FR 61638), 
FDA requested public comment on the proposed collection of information. 
FDA received one comment, but it was not directly related to the 
information collection.
    FDA estimates the burden of this collection as follows:

[[Page 1188]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                     Annual
                                                         No. of    Frequency    Total Annual      Hours    Total
                   21 CFR Section                     Respondents     per     [chyph]Responses     per     Hours
                                                                    Response                    Response
----------------------------------------------------------------------------------------------------------------
803.19                                                      25           1            25             1       75
----------------------------------------------------------------------------------------------------------------
803.30                                                   1,000           3         3,000             1    3,000
----------------------------------------------------------------------------------------------------------------
803.33 FDA Form 3419                                     1,000           1         1,000             1    1,000
----------------------------------------------------------------------------------------------------------------
803.40                                                      50          10           500             1      500
----------------------------------------------------------------------------------------------------------------
803.50                                                   1,500          34        51,000             1    51,000
----------------------------------------------------------------------------------------------------------------
803.55 FDA Form 3417                                       700           5         3,500             1    3,500
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     59,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.


                                 Table 2.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                        Annual      Total
                   21 CFR Section                       No.  of     Frequency per   Annual    Hours per    Total
                                                     Recordkeepers  Recordkeeping  Records  Recordkeeper   Hours
----------------------------------------------------------------------------------------------------------------
803.17                                                   3,200              1       3,200        3.3      10,560
----------------------------------------------------------------------------------------------------------------
803.18\2\                                               39,000              1      39,000        1.5      58,500
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     69,060
----------------------------------------------------------------------------------------------------------------
\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.
\2\ Include an estimated 35,000 medical device distributors. Although they do not submit medical device reports,
  they must maintain records of complaints.

    The agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the medical device 
report (MDR) requirements as part of their internal quality control 
system.
    Part 803 requires user facilities to report incidents where a 
medical device caused or contributed to a death or serious injury to 
the device manufacturer and to FDA (in case of death). Manufacturers of 
medical devices are required to report to FDA when they become aware of 
information indicating that one of their devices may have caused or 
contributed to death or serious injury or has malfunctioned in such a 
way that should the malfunction recur, it would be likely to cause or 
contribute to death or serious injury. Device importers report deaths 
and serious injuries to the manufacturers and FDA. Importers report 
malfunctions only to the manufacturers, unless they are unknown. If the 
manufacturer is unknown, the importer sends the reports to FDA.
    The agency has estimated that on average, 1,800 entities annually 
would be required to establish new procedures or revise existing 
procedures in order to comply with MDR provisions. For those entities, 
a one-time burden of 10 hours is estimated for establishing written MDR 
procedures. The remaining manufacturers, user facilities, and importers 
which are 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).

    Dated: January 2, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-361 Filed 1-8-03; 8:45 am]
BILLING CODE 4160-01-S