[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Notices]
[Pages 821-823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0437]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Third-Party Review Under the Food and Drug Administration Modernization 
Act, Third-Party Premarket Submission Review, and Quality System 
Inspections Under the United States/European Community Mutual 
Recognition Agreement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 4, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and

[[Page 822]]

Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 
202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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 Devices; Third-Party Review Under FDAMA, Third-Party Premarket 
Submission Review, and Quality System Inspections Under U.S./E.C. 
Mutual Recognition Agreement (OMB Control Number 0910-0378)--Extension

    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in 
the private sector to review certain premarket applications and 
notifications. Participation in this third-party review program by 
accredited persons is entirely voluntary. A third party wishing to 
participate will submit a request for accreditation to FDA. Accredited 
third-party reviewers have the ability to review a manufacturer's 
submission under section 510(k) of the act (21 U.S.C. 360(k)) for 
selected devices. After reviewing a submission, the reviewer will 
forward a copy of the 510(k) submission, along with the reviewer's 
documented review and recommendation to FDA. Third-party reviews should 
maintain records of their 510(k) reviews and a copy of the 510(k) for a 
reasonable period of time, usually a period of 3 years. This 
information collection will allow FDA to continue to implement the 
accredited person review program established by FDAMA and improve the 
efficiency of 510(k) review for low-to-moderate risk devices.
    The third-party program under the U.S/European Community (E.C.) 
Mutual Recognition Agreement (MRA) is intended to implement that part 
of the U.S./E.C. MRA that covers the exchange of quality system 
evaluation reports for all medical devices and premarket evaluation 
reports for selected low-to-moderate risk devices. Under the MRA, firms 
may apply to become designated as a U.S. conformity assessment body 
(CAB). Firms who are designated will be qualified to conduct quality 
system evaluations for all classes of devices and product type 
evaluations and verifications for selected devices based on European 
Union (EU) requirements under the voluntary third-party program 
authorized by MRA. Firms designated as EU CABs could conduct quality 
system evaluations for all classes of devices and premarket 510(k) 
evaluations for selected devices based on FDA's requirements. Under the 
voluntary third-party program, reports of these evaluations would be 
submitted by the EU CABs to FDA. The EU CABs would also be required to 
maintain copies of their evaluation reports for a period of no less 
than 3 years.
    In the Federal Register of October 14, 2004 (69 FR 61021), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                            No. of         Annual Frequency      Total Annual          Hours per
                        Item                              Respondents        per Response          Responses           Response           Total Hours
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Requests for accreditation                                           15                   1                  15                  24                 360
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510(k) reviews conducted by accredited third parties                 15                  14                 210                  40               8,400
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Premarket reports by EU CABs                                          9                   5                  45                  40               1,800
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Quality system reports by EU CABs                                     9                   4                  36                  32               1,152
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Total                                                                                                                                            11,712
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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 Burden\1\
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                                                        No. of Record-     Annual Frequency      Total Annual      Hours per Record-
                        Item                                keepers        per Recordkeeper         Records             keeper            Total Hours
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510(k) reviews                                                       15                  14                 210                  10               2,100
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Premarket reports by EU CABs                                          9                   5                  45                  10                 450
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Quality system reports by EU CABs                                     9                   4                  36                  10                 360
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Total                                                                                                                                             2,910
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burdens are explained as follows:

I. Reporting

A. Requests for Accreditation

    Under the agency's third-party review pilot program, the agency 
received 37 applications for recognition as third-party reviewers, of 
which the agency recognized 7. In the past 3 years, however, the agency 
has averaged receipt of 15 applications for recognition of third-party 
review accredited persons, and 9 EU CABS. The agency has accredited 15 
of the applicants to conduct third-party reviews, and 9 EU CABs.

[[Page 823]]

B. 510(k) Reviews Conducted by Accredited Third Parties

    In the 18 months under the third-party review pilot program, FDA 
received only 22 total 510(k)s that requested and were eligible for 
review by third parties. Because the third-party review program is not 
as limited in time as the pilot program, and is expanded in scope, the 
agency anticipates that the number of 510(k)s submitted for third-party 
review will remain the same as they were during the last OMB approval 
in 2001. The agency has experienced that the number of 510(k)s 
submitted by accredited persons for third-party review since the last 
OMB approval in 2001 has been approximately 210 annually, which is 14 
annual reviews per each of the estimated 15 accredited reviewers.
1. Premarket Reports
    Under this program, EU CABs will be able to perform third-party 
evaluations for certain products produced in Europe for export to the 
United States. EU CABs would be required to submit to FDA reports of 
their evaluations. Based upon information gathered since this 
collection was last reviewed in 2001, the agency has experienced that 
nine European manufacturers have not received any third-party requests 
for review annually. The agency estimates, based on dialog with EU 
officials and actual experience, nine firms will be designated to act 
as EU CABs.
2. Quality System Reports
    Under this program, EU CABs will be able to perform third-party 
evaluations of the quality systems established by manufacturers of 
European products produced for export to the United States. EU CABs 
would be required to submit to FDA reports of their evaluations. Based 
upon information gathered during the negotiation of the U.S./E.C. MRA 
and actual experience since the collection was last approved by OMB in 
2001, the agency anticipates that European manufacturers will request 
third-party audits for approximately 36 medical device products 
annually. The agency estimates that nine EU CABs will perform these 
evaluations.

II. Recordkeeping

    Third-party reviewers are required to keep records of their review 
of each submission. The agency anticipates approximately 210 annual 
submissions of 510(k)s for third-party review.
    As stated previously, firms designated as EU CABs will be able to 
perform third-party evaluations of quality systems and premarket 
submissions for certain products produced for export to the United 
States. Such review will be conducted consistent with FDA's regulatory 
requirements, and FDA will require the reviewers to keep, in their 
records, a copy of the report that they submit to FDA for each review. 
The agency anticipates that 45 premarket reports and 36 quality system 
reports will be generated and required to be maintained by EU CABs 
annually. The agency further estimates that each reviewer will require 
no more than 10 hours (2 hours per recordkeeping per report) for each 
to maintain such records annually.

    Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-109 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S