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    • 522 Postmarket Surveillance Studies

    Metadata Updated: July 11, 2025

    The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.

    Access & Use Information

    Public: This dataset is intended for public access and use. License: See this page for license information.

    Downloads & Resources

    References

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268064.htm

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 3d55fceb-5248-4475-b675-503312202d0d
    Data First Published 2021-02-25
    Data Last Modified 2013-11-01
    Category FDA
    Public Access Level public
    Bureau Code 009:10
    Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
    Metadata Catalog ID https://healthdata.gov/data.json
    Schema Version https://project-open-data.cio.gov/v1.1/schema
    Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
    Harvest Object Id 377e0cd9-bf97-42a1-a1a2-3f423899c08c
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Related Documents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268064.htm
    Source Datajson Identifier True
    Source Hash acb1fc49dbd062eb197fc9d3e39a7e4680ed272e95ceb023c9b8bd08dfd276d6
    Source Schema Version 1.1

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