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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

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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