FDA unveils 25 initial 510(k) changes, refers controversial recommendations to the Institute of Medicine (IOM)
Health Care Law Mon
.
2011 Jun;2011(6):2-7.
Authors
Melissa Gilmore
1
,
Joseph J Hylak-Reinholtz
Affiliation
1
McGuire Woods LLP, Washington, DC, USA. mgilmore@mcguirewoods.com
PMID:
21748924
No abstract available
MeSH terms
Device Approval / legislation & jurisprudence*
National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division*
United States
United States Food and Drug Administration*