Regulating molecular diagnostic assays: Developing a new regulatory structure for a new technology

Expert Review of Molecular Diagnostics

Volumn 11, Issue 4, 2011, Pages 367-381

  Gibbs, Jeffrey N ^a  

^a Hyman Phelps & McNamara PC   (United States)

Author keywords

diagnostic regulation; FDA; Food and Drug Administration; in vitro diagnostics; molecular diagnostics; personalized medicine; regulatory framework

Indexed keywords

DIAGNOSTIC ACCURACY; ENZYME IMMUNOASSAY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; MEDICAL PRACTICE; MOLECULAR DIAGNOSIS; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

GOVERNMENT REGULATION; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; POLICY; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955748002     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/erm.11.20     Document Type: Review

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