FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems. FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017. The proposed process […]
Form 483
Senate bill aims to streamline FDA inspections process
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 […]
FDA: US medical device inspections down in 2015
The FDA said this week that it inspected fewer U.S. medical device plants last year than in 2014, but sent inspectors to more overseas facilities. The overall number of quality systems inspections fell -5% to 2,104 during calendar 2015, the federal safety watchdog said, but U.S. inspections were down -5% to 1,484 while foreign inspections rose […]
