Summary:
- The FDA Manufacturing PreCheck Pilot Program is a new initiative by the U.S. Food and Drug Administration (FDA) to help streamline the process of getting new medical products approved and on the market.
- The program allows manufacturers of certain medical devices and drugs to submit their quality management system information to the FDA in advance, so the FDA can review it before the actual product application is submitted.
- This can help reduce the time and effort required to get new medical products approved, making them available to patients more quickly.