The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to document and review their testing in order to obtain premarket submission. The final guidelines released on the ASCA pilot program will reduce review time and increase testing confidence.
The agency will host a webinar on October 22nd regarding the documents.
Read more here.