ARTICLE | Politics & Policy

FDA to establish patient engagement advisory committee

September 19, 2015 12:55 AM UTC

FDA said it would establish the Patient Engagement Advisory Committee, which will advise the agency on issues related to patient engagement in medical device regulation.

The committee may address topics such as the process by which patients should provide input during the medical device product life cycle and methods for incorporating information from patient preference studies or patient-reported outcomes into device labeling. Proposed topics of discussion are open for public comment until Nov. 20. ...