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    • FDA Recognized Consensus Standards

    Metadata Updated: July 26, 2023

    This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.

    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/Standards/default.htm

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 26, 2023
    Data Update Frequency R/P3M

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 26, 2023
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 4b318035-9f0e-4f7e-b4ff-c70fd57b4994
    Data First Published 2021-02-25
    Data Last Modified 2023-07-26
    Public Access Level public
    Data Update Frequency R/P3M
    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 ac711ca9-f50b-4e58-b457-7afb66ad1e26
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Related Documents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm
    Source Datajson Identifier True
    Source Hash b211d5b4ca38937845d982edebdc85a09f23dd42
    Source Schema Version 1.1

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