Evaluation of premarket approval applications (PMA) by the Food and Drug Administration (FDA) is a multi-step process in which we evaluate whether reasonable assurance of device safety and effectiveness has been demonstrated. To provide reasonable assurance, or the continued assurance, of safety and effectiveness of an approved device, we may require a postapproval study (PAS) as a condition of approval in a PMA approval order under 21 CFR 814.82(a)(2) and 21 CFR 814.82(a)(9).

A PAS is usually a clinical or non-clinical study,  as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device.
As described in “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval,”  FDA may consider it acceptable to collect certain data in the postmarket setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device at the time of premarket approval


The purpose of this guidance document is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing:
• procedural information;
• recommendations concerning the format, content, and review of PAS-related submissions;
• recommendations to help facilitate FDA’s review of a PAS protocol in a timely manner;
• recommendations for study timelines including enrollment milestones and study completion;
• revised definitions to PAS status categories that we believe better reflect progress of the PAS; and
• revised FDA review time goals for PAS-related submissions


In general, FDA’s guidance documents 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 guidance means that something is suggested or recommended, but not required.