Post-Approval Studies

Metadata Updated: November 10, 2020

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 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 9cbff0af-fc5b-41b3-910d-8d66e493e0f5
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/post-approval-studies
License https://opendatacommons.org/licenses/odbl/1.0/
Program Code 009:005
Source Datajson Identifier True
Source Hash bb0fb459e11e056de29864791b1e57701b7fbb09
Source Schema Version 1.1

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