• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

  • Print
  • Share
  • E-mail
-
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.

Learn more...

            

Registry Database


 
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Revised/Replaced Study
522 Number / Requirement Number PS110002 / PSS001
Date Current Plan Accepted 03/16/2016
Study Name Registry Database
Root Document Number P000023  P000035 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study design was revised/replaced by the other remaining PS Requirements.




-
-