Industry Offers Mixed Reaction to Changes to Advisory Panels

Some devicemakers welcome changes the FDA is making to device advisory panels to focus more on scientific data, but others aren’t so sure. Panels now will vote only on scientific questions concerning the safety and effectiveness of a new device and its risk versus benefit. They will no longer vote to recommend approval or conditions for approval. The Southeastern Medical Device Association thinks the changes will provide more resources and transparency to the process. Other trade groups say it’s too soon to predict any impact.
Devices & Diagnostics Letter