In search of a coherent framework: options for FDA oversight of genetic tests.
Genetics and Public Policy Center, Berman Institute of Bioethics, Georgetown University Law Center, USA.
Gail H
GH
Javitt
D003132:Commerce / Q000331:legislation & jurisprudence; D018795:Device Approval; D003955:Diagnostic Tests, Routine / Q000145:classification / Q000379:methods*; D004864:Equipment and Supplies / Q000145:classification; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration