FDA Guidance Aims to Improve Demographic Data for Devices
The FDA released guidance to help the medical device industry analyze and report clinical study data on age, racial and ethnic subgroups, noting there is relatively little clinical trial information available on these subgroups.
The policy set forth in the new guidance applies to clinical studies where device safety, effectiveness or benefit-risk profile is expected to vary across the different subgroups.
The final guidance amends the draft version released in June 2016 in response to industry concerns. AdvaMed, for example, cautioned that extreme considerations of any clinically meaningful differences across the subgroups “could limit patient access to innovative medical devices.” The agency clarified that the considerations should be taken into account if it is feasible to do so.