FDA updates patient-preference guidance for devices

FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released final guidance on the use of patient preference information to inform regulatory decisions concerning medical devices, including premarket approvals and de novo submissions.

The agency released draft guidance on the subject in May 2015. Spokesperson Deborah Kotz told BioCentury the new guidance clarifies how stakeholders can submit patient preference information to FDA, includes a section about adding relevant information to decision summaries, and updates recommendations to manufacturers about device labeling (see BioCentury Extra, May 13, 2015). ...