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: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020
Publisher Department of Health & Human Services
Unique Identifier Unknown
Maintainer
Identifier cffc9661-6d5a-4b42-9fec-fdd96d025685
Data First Published 2015-03-31
Data Last Modified 2016-04-05
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
Homepage URL https://healthdata.gov/dataset/fda-recognized-consensus-standards-0
License https://opendatacommons.org/licenses/odbl/1.0/
Program Code 009:005
Source Datajson Identifier True
Source Hash f9ad2179ab5acec679a4cf54e482eaf19614de21
Source Schema Version 1.1

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