Devices not on FDA's agenda for MRA (mutual recognition agreement) meeting:
This article was originally published in Clinica
Executive Summary
The FDA's first public meeting to discuss progress in implementing the mutual recognition agreement (MRA) between the US and the European Union will focus on the agreement as it relates to pharmaceuticals, and not medical devices. The agency initially wanted to discuss the medical device sectoral annex and the drugs sectoral annex of the accord at its December 8 meeting but changed its mind because of differences between the two, according to Charles Gaylord in the FDA office of international and constituent relations. No date has been set for a public meeting on the section of the agreement covering devices, but it will probably take place within a few months, he said.