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GUIDANCE DOCUMENT

Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order Draft Guidance for Industry and Food and Drug Administration Staff May 2021

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2005-D-0027


Docket Number:
FDA-2005-D-0027
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Evaluation of premarket approval applications (PMA) by the Center for Devices and Radiological Health (CDRH) of 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 post-approval 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The purpose of this draft guidance document, when finalized, is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing: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; and
  • updates to the final guidance entitled "Procedures for Handling Post-Approval Studies Imposed by PMA Order" dated June 2009, including:
    • 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.
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