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  • FDA Recognized Consensus Standards

    Metadata Updated: November 10, 2020

    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: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

    Downloads & Resources

    References

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm

    Dates

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

    Metadata Source

    Harvested from Healthdata.gov

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date November 10, 2020
    Publisher U.S. Food and Drug Administration
    Unique Identifier Unknown
    Maintainer
    Identifier 4b318035-9f0e-4f7e-b4ff-c70fd57b4994
    Data First Published 2019-02-28
    Data Last Modified R/P3M
    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
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
    Program Code 009:005
    Related Documents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm
    Source Datajson Identifier True
    Source Hash 3b10c2e79450bbed07d7bc32bacc9b206fde57ce
    Source Schema Version 1.1

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