Regulatory approval pathways for molecular diagnostic technology

Methods in Molecular Biology

Volumn 823, Issue , 2012, Pages 409-420

  Liotta, Lance A ^a   Petricoin III, Emanuel F ^a  

^a GEORGE MASON UNIVERSITY   (United States)

Author keywords

510(k); Accuracy; Approval; Biomarker; Code of Federal Regulations; Devices , Diagnostic; Molecular profiling; Precision; Premarket approval application

Indexed keywords

ARTICLE; DEVICE APPROVAL; DIAGNOSTIC TEST APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INSTRUMENTATION; LEGAL ASPECT; METHODOLOGY; MOLECULAR DIAGNOSIS; UNITED STATES;

DEVICE APPROVAL; DIAGNOSTIC TEST APPROVAL; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 82355171052     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-60327-216-2_27     Document Type: Article

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