Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." Patients provide valuable input to FDA in a variety of forms. This guidance describes the principles and concepts that FDA recommends sponsors and other interested parties consider when collecting and submitting patient preference information (PPI), discusses FDA's inclusion of PPI in its decision summaries, and provides recommendations for the inclusion of such information in device labeling for certain devices. PPI can be used in FDA decision making across the total product life cycle, including during review of investigational device exemption (IDE) applications, requests for a Breakthrough Device designation, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, premarket notifications (510(k)s), or for FDA decisions involving administrative, enforcement, or other actions.