FDA Recognized Consensus Standards

Metadata Updated: August 9, 2018

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 June 19, 2015
Metadata Updated Date August 9, 2018

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date June 19, 2015
Metadata Updated Date August 9, 2018
Publisher Department of Health & Human Services
Unique Identifier cffc9661-6d5a-4b42-9fec-fdd96d025685
Maintainer
admin
Maintainer Email
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://www.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 98f5a54b-5b9b-428c-98b4-42838d841118
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
License http://opendefinition.org/licenses/odc-odbl/
Data Last Modified 2016-04-05
Program Code 009:005
Source Datajson Identifier True
Source Hash 535d7216f8a207bd5077c95f2c8877787b693aea
Source Schema Version 1.1

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