New Bill Would Harmonize FDA Device Inspections

A bipartisan bill introduced last week in the Senate seeks to harmonize FDA’s medical device inspections process worldwide by eliminating variations between countries.

The bill (S. 404), sponsored by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.), would also allow the FDA to inform manufacturers in advance of documents needed for audits, and provide an approximate time that audits would be conducted.