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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