When Worlds Collide: The Theory of Real-World Evidence Meets Reality – Part II

May 23, 2024By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert

We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications.  In response to the post, we did receive feedback from a company that had had the good fortune to have very positive experiences with RWD/RWE.  In the interest of fairness, we want to report that FDA was very receptive to the use of that information in several different applications.  (In the interest of fairness, we also heard from others who had the opposite experience.)

On the one hand, it is good to know that CDRH is capable of taking full advantage of RWD/RWE and using it to meet the data requirements.  This company’s positive experience was with a particular Division, with which one of us also had a positive experience with RWD/RWE.

On the other hand, it is frustrating to know that while CDRH is capable of utilizing RWD/RWE to meet data requirements, it does so sporadically and inconsistently.  It is not clear why one company’s experiences with a Division have not been consistently replicated across the Center.  And it is even more concerning that in the recent proposed ban of electrical stimulation devices, CDRH has publicly taken such a negative stance towards RWD/RWE, applying criteria that RWD/RWE will never be able to satisfy.

So, we appreciate the feedback from the reader that had such favorable outcomes with its RWD/RWE.  Perhaps someday that will be the norm, rather than the exception, and therefore not newsworthy.

Categories: Medical Devices