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    • 522 Postmarket Surveillance Studies

    Metadata Updated: March 16, 2021

    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 March 16, 2021

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date March 16, 2021
    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
    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 4a09ac2e-0f49-480a-8501-b0d42df268db
    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 37bbf27c24e915c86406d1233f385c47d874190b
    Source Schema Version 1.1

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