10 July 2018 - Over time, as our experience with new medical products expands, our knowledge about how best to maximise their benefits and minimise any potential risks, sharpens with each data point we gather. 

Every clinical use of a product produces data that can help better inform us about its safety and efficacy.

The FDA is committed to developing new tools to help us access and use data collected from all sources. This includes ways to expand our methodological repertoire to build on our understanding of medical products throughout their lifecycle, in the post market. We don’t limit our knowledge to pre-market information, traditional de novo post-market studies, and passive reporting. Newer methodologies enable us to collect data from routine medical care and develop valid scientific evidence that’s appropriate for regulatory decision making to help patients and health care providers prevent, diagnose, or treat diseases.

Read FDA blog