FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?
Clin Chem
.
2013 Jul;59(7):1017-22.
doi: 10.1373/clinchem.2013.204958.
Epub 2013 Mar 27.
Authors
Mitchell G Scott
1
,
Edward R Ashwood
,
Thomas M Annesley
,
Debra G B Leonard
,
Michael C Burgess
Affiliation
1
Department of Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA. mscott@labmed.wustl.edu
PMID:
23536512
DOI:
10.1373/clinchem.2013.204958
No abstract available
MeSH terms
Clinical Laboratory Techniques / standards*
Government Regulation*
Legislation, Medical*
United States
United States Food and Drug Administration