Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited Page: 4 of 32
This report is part of the collection entitled: Government Accountability Office Reports and was provided to UNT Digital Library by the UNT Libraries Government Documents Department.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
Contents
Abbreviations
BLA biologics license application
CBER Center for Biologics Evaluation and Research
CDRH Center for Devices and Radiological Health
FDA Food and Drug Administration
FDCA Federal Food, Drug, and Cosmetics Act
GMP good manufacturing practices
HHS Department of Health and Human Services
MDUFMA Medical Device User Fee and Modernization Act of 2002
PMA premarket approval
This is a work of the U.S. government and is not subject to copyright protection in the
United States. It may be reproduced and distributed in its entirety without further
permission from GAO. However, because this work may contain copyrighted images or
other material, permission from the copyright holder may be necessary if you wish to
reproduce this material separately.GAO-04-1022 FDA's Review of Device Applications
Page ii
Upcoming Pages
Here’s what’s next.
Search Inside
This report can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Report.
United States. Government Accountability Office. Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited, report, August 30, 2004; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc298608/m1/4/: accessed March 28, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.