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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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Post-market Surveillance Study (PSS)

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Study Status Progress Inadequate
522 Number / Requirement Number PS150001 / PSS001
Date Current Plan Accepted 02/23/2021
Study Name Post-market Surveillance Study (PSS)
Root Document Number K142282 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs

Post-market Surveillance Study (PSS) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 MONTH REPORT 07/29/2016 10/13/2016 Overdue/Received
1 yr report 01/28/2017 02/17/2017 Overdue/Received
18 month report 07/28/2017 09/06/2017 Overdue/Received
2 year report 01/28/2018 03/13/2018 Overdue/Received
30 month report 07/29/2018 07/30/2018 Overdue/Received
3 yr report 01/29/2019 01/28/2019 On Time
4 year report 01/28/2020   Overdue
final report 03/15/2021 03/15/2021 On Time