Brad Perriello, Executive Editor
A bill filed this week in the U.S. Senate seeks to streamline FDA inspections of medical device manufacturers by creating a more transparent, risk-based approach applied consistently across the federal watchdog’s regional offices.
Sponsored by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.), the bill would direct Health & Human Services Dept. secretary Dr. Tom Price to “adopt a uniform process and uniform standards applicable to inspections of domestic and foreign device establishments.”
That process would include advance notice of the type and nature of routine inspections, excluding “f0r-cause” investigations, “within a reasonable time before such inspection,” according to the bill, known as S.404 or “A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.”