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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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Postmarket Surveillance


 
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General
Study Status Study Pending
522 Number / Requirement Number PS210001 / PSS001
Date Current Plan Accepted  
Study Name Postmarket Surveillance
Root Document Number K193371 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs


Postmarket Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/21/2021    
12 month report 05/20/2022    
18 month report 11/16/2022    


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