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.

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Dates

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

Metadata Source

Data.json Data.json Metadata
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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	admin
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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