Bloomberg Law
Jan. 25, 2022, 5:03 PM

Patient Voices Get Focus in Guidance for Medical Device Studies

Celine Castronuovo
Celine Castronuovo

Medical device makers should use rating scales, questionnaires, and other tools to collect patient feedback on a product’s safety and effectiveness, the FDA said in guidance aimed at better integrating patient voices in product studies.

The Food and Drug Administration’s two final guidance documents, released Tuesday, seek to address repeated complaints from patient groups that device makers don’t adequately consider their perspectives in clinical trials, which they say limits the effectiveness of the products marketed for them.

“FDA believes medical device clinical studies designed with patient input may help to address common challenges faced” in those studies, such as speeding ...