Post-Approval Studies

Metadata Updated: March 16, 2021

The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.

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 March 16, 2021

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date March 16, 2021
Publisher U.S. Food and Drug Administration
Unique Identifier Unknown
Maintainer
Identifier 910c9a83-0447-4c05-b418-c2f49dd83b1b
Data First Published 2021-02-25
Data Last Modified 2013-11-01
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
Harvest Object Id 9cdb79fd-af5d-4626-a175-095aa1363fe3
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
License http://opendefinition.org/licenses/odc-odbl/
Program Code 009:005
Source Datajson Identifier True
Source Hash e276ef5a200e60407e3702bcdfc259117074bf33
Source Schema Version 1.1

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