The Framework Report should be considered an initial thought piece that outlines a range of considerations for how industry and FDA might incorporate patient preference information into the regulatory approval process. The Report is not intended to be a prescriptive, “how-to” guide, nor does it purport to be a definitive document about incorporating patient preference information into the regulatory process. Rather, it is intended to be an initial version of what MDIC hopes will be a working document about this emerging field that is updated over time as industry, FDA, and others gain more experience with collecting and using patient preference information in the regulatory process.
The Medical Device Innovation Consortium (MDIC) is the first-ever public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. Our Mission: Faster, Saf...