FDA is clearing up confusion about what types of changes to existing medical devices require new 510(k) submissions by updating its 1997 guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” The 2011 Version has been published with the intent of clarifying the requirements in an effort to improve predictability, consistency, and transparency of the premarket review program. When conducting diligence on medical device manufacturers, investors should be aware of historical and planned changes to existing devices. These changes may need to follow the new requirements. Click here to read more. Contact Melissa Gilmore, McGuireWoods’ FDA counsel at mgilmore@mcguirewoods.com.
