Device Industry Wants FDA To Adopt ‘Least Burdensome’ RWE Approach

Industry associations are welcoming a greater role for real-world evidence FDA points to in its latest draft guidance on the issue, but they say the agency must embrace a “least burdensome” approach that will allow flexibilities in the use of the data. FDA released the draft guidance for generating real-world evidence (RWE) for medical device reviews and regulatory decisions in December, and it is reviewing stakeholders’ comments. In the draft, FDA’s Center for Devices and Radiological Health (CDRH) says RWE...