FDA Seeks Data To Inject Patient Preferences In Device Reviews, Labeling

FDA in new draft guidance invites device makers to voluntarily submit scientifically valid patient preference data along with premarket approval applications (PMAs), humanitarian device exemption applications and de novo requests for use by the agency in benefit-risk assessments, and the agency says such information could make its way onto device labels. The data potentially could lead to FDA imposing conditions of approval based on patient preference data used to complete the benefit-risk assessment, the draft says. The agency also lays...