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    • Post-Approval Studies

    Metadata Updated: March 16, 2021

    The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) 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

    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 910c9a83-0447-4c05-b418-c2f49dd83b1b
    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 9cdb79fd-af5d-4626-a175-095aa1363fe3
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Source Datajson Identifier True
    Source Hash e276ef5a200e60407e3702bcdfc259117074bf33
    Source Schema Version 1.1

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