Home » Industry Offers Mixed Reaction to Changes to Advisory Panels
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
Devices & Diagnostics Letter
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May