FDA Establishes Process for Designating Conformity Assessment Bodies Under US-EU MRA

Summary

The US Food and Drug Administration (FDA) is establishing a process for designating Conformity Assessment Bodies (CABs) under the Mutual Recognition Agreement (MRA) between the US and the European Community (EC), which was signed in London on May 18, 1998. The FDA has published a proposed rule outlining the requirements for CABs to become eligible for designation under the Medical Devices Annex of the MRA.