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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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PSS


 
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General
Study Status Plan Overdue
522 Number / Requirement Number PS200008 / PSS001
Study Name PSS
Root Document Number K200467 
General Study Protocol Parameters
Study Population




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