Can RWE Improve Odds in FDA Applications for Medical Devices?

Christian Howell, Vice President and General Manager of Medical Devices and Diagnostics at Aetion, provides insight into when and how RWE (real world evidence) can be used in regulatory approval applications for medical devices. Over 90 FDA approvals included RWE and this number is expected to significantly increase. He discusses points raised by Dr. Jeff Shuren and Dr. Daniel Caños of the FDA’s CDRH (Center for Devices and Radiological Health).

Lowell notes, “[I]n early development, RWE supports understanding of the standard of care, unmet need, and the burden and natural history of a disease. Manufacturers can further leverage RWE to optimize clinical trial design, as well as to supplement RCT data in regulatory submissions. Within the realm of HEOR and market access, RWE can inform budget impact and cost-effectiveness models for relevant populations.” Read more here.

(Source: Christian Howell, Aetion, 3/25/2021)