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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Study Status Terminated
522 Number / Requirement Number PS130021 / PSS001
Date Current Plan Accepted  
Study Name PSS
Root Document Number K020110 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Design Description Postmarket surveillance (522) order no longer applies. Indication for Use revised and no longer include the indication subject of the 522 order.