The FDA has released draft guidance on changes to its program to accredit third-party entities to review certain medical device applications. The draft guidance, based on the International Medical Device Regulators Forum's proposal to create a unified program for medtech auditors, covers compliance with the FDA Safety and Innovation Act, including a provision regarding third-party firm accreditation. Firms must seek reaccreditation every three years.
FDA issues draft guidance on third-party device review program
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