Agreement on Mutual Recognition Between the United States of America and the European Community; Third Party Review Program Under the Sectoral Annex on Medical Devices; Conformity Assessment Bodies

概要

The Food and Drug Administration (FDA) is identifying the process for designating Conformity Assessment Bodies (CAB's) under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA). The MRA was signed in London on May 18, 1998, but it has not entered into force. FDA has published a proposed rule on the parts of the MRA affecting FDA-regulated products. This notice announces the process for CAB's to become eligible for designation under the Sectoral Annex on Medical Devices (Medical Devices Annex). The availability of the draft guidance detailing the requirements for performing evaluations, training for CAB's, and content of evaluation reports by FDA is announced elsewhere in this issue of the Federal Register. Also announced elsewhere in this issue of the Federal Register is an emergency processing request for Office of Management and Budget review of the information collection provisions of this notice. FOR FURTHER INFORMATION CONTACT: Regarding the U.S./European Community MRA: John F. Stigi, Director, Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological