Home / Positions + Comments / CPC Comments on FDA Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements

CPC Comments on FDA Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements

The CPC’s comments addressed three issues:

The need for better clarification between enhancements and recalls.
Whether FDA is expanding regulatory reporting requirements under 21 C.F.R. Part 806 through the guidance document.
Whether some of the guidance on enhancements addresses topics better reserved for new guidance FDA is developing on premarket notifications following product modifications.