Federal Register Notice: FDA is making available a draft guidance for industry entitled Patient Preference Information — Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling. It provides guidance on collecting and submitting patient preference information that may be used by FDA staff in decisionmaking relating to PMAs, Humanitarian Device Exemption applications, and de novo requests. The document also outlines considerations for including patient preference information in labeling for patients and health care professionals. To download this guidance, click here. To view this notice, click here.