Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (the Act) are subject to periodic reporting requirements set forth in the PMA approval order (21 CFR 814.82(a), 21 CFR 814.84(b)). This guidance document describes the information required to be submitted in annual reports under 21 CFR 814.84(b), additional information requirements that may be imposed by approval order under 21 CFR 814.82(a), and FDA’s recommendations for the level of detail the applicant should provide in the annual report. It also identifies the steps FDA staff generally take when reviewing annual reports, the resources available to assist staff in their reviews, and the actions they may recommend after reviewing annual reports. This guidance document is intended to help ensure that annual reports are complete and that the actions of CDRH and CBER staff are consistent.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.