Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices: Third-Party Review Program Under U.S./EC MRA

In compliance with section 3507 of the PRA (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 Program Under U.S./EC MRA (OMB Control Number 0910-0378--Extension)

The third-party program under the United States/European Community Mutual Recognition Agreement (U.S./EC MRA) is intended to implement that part of 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 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 EC CAB's could, in turn, 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 EC CAB's to FDA. EC CAB's would also be required to maintain copies of their evaluation reports. In the Federal Register of August 4, 1998 (63 FR 41573), the agency requested comments on the proposed collection of information. The agency received two comments. One comment questioned why FDA chose 12 as the number of U.S. CAB's, when Europe already has 20. The agency's estimate is based on discussions with the National Institute of Science and Technology of the U.S. Department of Commerce and officials of other standards organizations as well as firms who have expressed interest directly to FDA. FDA still believes that 12 is the appropriate number. The other comment questioned why FDA did not include all eligible class I and class II devices in the program. FDA did not include in the program three class I devices that are regulated by the Center for Biologics Evaluation and Research (CBER), because FDA determined that it would not be cost effective to train CBER employees in the program for only three devices. FDA included in the program the 97 class II devices for which guidance and/or

recognized standards exist and which represent 60 percent of the 510(k)s we receive each year. If the program is successful, FDA will add additional devices, as appropriate. FDA estimates the burden of this collection as follows:

Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Item No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- Requests for designation as U.S. CAB 12 1 12 24 288 Premarket reports by EC CAB's 20 5 100 40 4,000 Quality system reports by EC CAB's 20 5 100 32 3,200 Total 7,488 ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Recordkeeping Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Item No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper ---------------------------------------------------------------------------------------------------------------- Records of evaluation of premarket submissions by EC CAB's 20 5 100 10 1,000 Records of evaluation of quality systems 20 5 100 10 1,000 Total 2,000 ---------------------------------------------------------------------------------------------------------------- \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 Designation as U.S. CAB

Under this program, U.S. firms may apply for designation as a U.S. CAB. Such designation will enable that firm to perform third-party evaluations of U.S. products for export to EC. Likewise, European firms may apply to be designated as EC CAB's, which will enable them to perform third-party evaluations of products to be exported to the United States. The application for nomination as an EC CAB does not represent an information collection burden subject to the PRA because the designation procedure is an internal process which 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. The agency anticipates, based on discussions with the National Institute of Science and Technology of the U.S. Department of Commerce and officials of other standards organizations, as well as firms who have expressed interest directly to FDA, that approximately 12 applications for designation as U.S. CAB's will be received.

B. Premarket Reports

Under this program, EC CAB's will be able to perform third-party evaluations for certain products produced in Europe for export to the United States. EC CAB's would be required to submit reports of their evaluations to FDA. Based upon information gathered during the negotiation of U.S./EC MRA, the agency anticipates that European manufacturers will request third-party evaluation for approximately 100 medical device products annually. The agency further estimates, based on dialogue with EC officials, that 20 firms will be designated to act as EC CAB's.

C. Quality System Reports

Under this program, EC CAB's 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. EC CAB's would be required to submit reports of their evaluations to FDA. Based upon information gathered during the negotiation of U.S./EC MRA, the agency anticipates that European manufacturers will request third-party evaluations for approximately 100 medical device products annually. The agency estimates that 20 EC CAB's will perform these evaluations.

II. Recordkeeping

As stated previously, firms designated as EC CAB's 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 evaluation 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 evaluation. The agency anticipates that 100 premarket reports and 100 quality system reports will be generated and required to be maintained by EC CAB's annually. Thus, the agency estimates that 100 records of evaluations of quality systems and premarket submissions will be retained by the designated EC CAB's. Based on experience with the Third-Party Review Pilot Program, which was announced in the Federal Register of April 3, 1996 (61 FR 14789), the agency anticipates that each recordkeeper will require no more than 2 hours of recordkeeping per review. The agency is estimating five reviews per respondent and a total of 10 hours per recordkeeper.

Dated: December 4, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-33054 Filed 12-11-98; 8:45 am] BILLING CODE 4160-01-F