The FDA’s Center for Devices and Radiological Health (CDRH) has published its analysis of regulatory submissions supported by real world evidence (RWE), and how it can be leveraged to bring new medical devices to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.
The FDA’s Center for Devices and Radiological Health (CDRH) clarified how we evaluate the relevance and reliability of RWD to determine whether they are sufficient for generating the types of RWE that can be relied on for FDA regulatory decision-making for medical devices, in a 2017 guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.
RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market. The experience of CDRH, exemplified by a recent analysis, illustrates the wide range of RWE that has been used in regulatory decisions.
Today, CDRH published the results of that analysis, which include 90 publicly available examples of different types of regulatory submissions supported by RWE. These examples come from the full continuum of clinical and device areas throughout CDRH and across the medical device total product life cycle but do not comprise an exhaustive list of all submissions that have relied on RWE.
Read more from the FDA.