Patient access to medical devices--a comparison of U.S. and European review processes
N Engl J Med
.
2012 Aug 9;367(6):485-8.
doi: 10.1056/NEJMp1204170.
Epub 2012 Aug 1.
Authors
Saptarshi Basu
1
,
John C Hassenplug
Affiliation
1
Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD, USA.
PMID:
22852882
DOI:
10.1056/NEJMp1204170
No abstract available
Publication types
Comparative Study
MeSH terms
Device Approval*
Equipment and Supplies
Europe
Health Services Accessibility*
Humans
Time Factors
United States
United States Food and Drug Administration