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Guidance Issuing OfficeCenter 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The purpose of this draft guidance document, when finalized, is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing: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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.