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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement

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Information about this document as published in the Federal Register.

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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 (the PRA).

DATES:

Submit written comments on the collection of information by February 13, 2002.

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.

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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.

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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 Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement (OMB Control No. 0910-0378)—Extension

The third-party program under the United States/European (U.S./EC) Community/Mutual Recognition Agreement (MRA) is intended to implement that part of the U.S./EC 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 examinations and verifications for selected devices based on EC requirements under the voluntary third-party program authorized by MRA. Firms designated as European Union (EU) CABs could conduct quality system evaluations for all classes of devices and premarket 510(k) evaluations for selected devices based on FDA 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.

FDA requests approval of the following collection of information:

Requests for Designation as U.S. CABs—Under this program, U.S. companies were allowed to apply for designation as a U.S. CAB. Such designation enabled the company to perform third-party reviews of U.S. products for export to the EU and third-party audits of quality systems established by manufacturers of medical devices manufactured for export to the EU. Third-party review of U.S. products Start Printed Page 1771for export and third-party audit of quality systems was elective and at the discretion of the manufacturer of the product. At the present time, only eight U.S. CABs are active. The agency is not accepting applications for U.S. CAB designation at this time and in the foreseeable future.

Premarket Reports by EU CABs—Under this program, EU CABs will be able to perform third-party evaluations for certain products manufactured in Europe for export to the United States. Third-party evaluation is elective and at the discretion of the manufacturer of the product.

Quality System Reports by EU CABs—Under this program, EU CABs will be able to perform third-party audits of the quality systems established by EU manufacturers of products manufactured for export to the United States. Third-party audit of quality systems is elective and at the discretion of the manufacturer of the product.

EU CABs must maintain records of their third-party evaluations of quality systems and premarket submissions for certain products manufactured for export to the United States for a period of no less than 3 years.

The program implements that part of the U.S./EC 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.

Respondents to this information collection are businesses or other for-profit organizations.

In the Federal Register of October 5, 2001 (66 FR 51050), the agency requested comments on the proposed collection of information. No comments were received.

Table 1.—Estimated Annual Reporting Burden1

ItemNo. of ­RespondentsAnnual Frequency ­per­­ResponseTotal Annual ­ResponsesHours per ­Response
Premarket Reports by EC CABs1155540
Quality System Reports by EC Cabs111516532
Total
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden1

ItemNo. of ­RecordkeepersAnnual Frequency per ­RecordkeepingTotal Annual RecordsHours per ­RecordkeeperTotal Hours
Premarket Reports by EC CABs1155510550
Quality System Reports by EC Cabs1115165101,650
Total2,200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The following is an explanation of the burden estimate.

I. Reporting Burden

A. Requests for Designation as U.S. CAB

U.S. firms who have applied and have been accepted for designation as a U.S. CAB will be able to perform third-party evaluations of U.S. products for export to the EU. Likewise, European firms who have applied and been designated as EC CABs, will be able to perform third- party reviews of products to be exported to the United States. The application for nomination as an EU CAB does not represent a paperwork burden subject to the PRA because the designation procedure is an internal process that is required by, and administered by, European authorities. Only the application for designation as a U.S. CAB represents a paperwork burden under the PRA. However, the agency has received 10 applications for designation as U.S. CABs, 8 of whom are still active. The agency is not accepting any applications at this time, and does .not anticipate accepting any applications in the near future. Thus burden for U.S. CAB designation is nonexistent at this time.

B. Premarket Reports

EU CABs are required to submit to FDA reports of their third-party evaluations. Based upon information gathered during the negotiation of the U.S./EC MRA, the agency anticipates that European manufacturers will request third-party review for approximately 55 to 100 medical device products annually. The agency expects that interest and participation in the program will increase with time. The agency further estimates based on dialogue with EC officials, that 11 firms will be designated to act as EC CABs.

C. Quality System Reports

EU CABs are required to submit to FDA reports of their third-party evaluations. Based upon information gathered during the negotiation of the U.S./EC MRA, the agency anticipates that European manufacturers will request third-party audits for approximately 165 medical device products annually. The agency estimates that 11 EU CABs will perform these evaluations.

II. Recordkeeping

FDA requires the reviewers to keep in their records a copy of the report that they submit to FDA for each review. The agency anticipates that 55 premarket reports and 165 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.

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Dated: January 7, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 02-854 Filed 1-11-02; 8:45 am]

BILLING CODE 4160-02-S