Premarket Review Pilot Aimed At Harmonization Ready For Launch At FDA
This article was originally published in The Gray Sheet
Executive Summary
Publication of a final guidance on harmonized premarket reviews clears the way for the U.S. component of an international pilot program
You may also be interested in...
Device Harmonization Hurdles On Horizon, CDRH Director Feigal Tells RAPS
Global harmonization efforts are making device product launches in different countries more difficult in the short term, according to CDRH Director David Feigal
Device Harmonization Hurdles On Horizon, CDRH Director Feigal Tells RAPS
Global harmonization efforts are making device product launches in different countries more difficult in the short term, according to CDRH Director David Feigal
First Concurrent U.S.-Japan STED Submission Is Under Way; FDA Pushes Pilot
The U.S. and Japan have agreed to evaluate the first summary technical document (STED) submitted simultaneously in the two countries