FDA oversight of laboratory-developed tests: Is it necessary, and how would it impact clinical laboratories?

Clinical Chemistry

Volumn 59, Issue 7, 2013, Pages 1017-1022

  Scott, Mitchell G ^a   Ashwood, Edward R ^b,c   Annesley, Thomas M ^d   Leonard, Debra G B ^e   Burgess, Michael C ^f  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ARUP LABORATORIES   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF MICHIGAN   (United States)

^e NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^f NONE

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; VITAMIN D;

ADVISORY COMMITTEE; CHEMILUMINESCENCE IMMUNOASSAY; CHOLESTEROL BLOOD LEVEL; CLINICAL LABORATORY; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LABORATORY DEVELOPED TEST; LABORATORY DEVICE; LABORATORY TEST; MASS SPECTROMETRY; MEDICAL DEVICE; MEDICAL PRACTICE; MEDICAL SERVICE; MOLECULAR PATHOLOGY; NEWBORN SCREENING; NOTE; OUTCOMES RESEARCH; PATIENT CARE; PERSONALIZED MEDICINE; REFERENCE VALUE; TASK PERFORMANCE; TURNAROUND TIME; UNIVERSITY HOSPITAL;

CLINICAL LABORATORY TECHNIQUES; GOVERNMENT REGULATION; LEGISLATION, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84879709406     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2013.204958     Document Type: Note

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