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Current Legislative and Regulatory Framework in the United States
Pages 31-36

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From page 31...
... It was only with the 1976 Medical Device Amendments to FDCA, however, 1 The section "Current Legislative and Regulatory Framework in the United States" is based on the remarks of Andrea Ferreira-Gonzalez, Professor of Pathology, Virginia Commonwealth University and Director, The Molecular Diagnostics Laboratory, Virginia Commonwealth University Health System; and Courtney Harper, Acting Director of the Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration.
From page 32...
... . Enacted in 1996 to protect health insurance coverage for workers -- and their families -- who change or lose their jobs, a major provision of HIPAA was to require the Department of Health and Human Services to write regulations aimed at protecting the privacy of individuals' identifiable personal health information should Congress fail to enact legislation offering such protection before August 31, 1999.4 Genetic Information Nondiscrimination Act (GINA)
From page 33...
... Government Accountability Office, Testimony Before the Special Committee on Aging, U.S. Senate, Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers, Statement of Gregory Kutz, Managing Director Forensic Audits and Special Investigations, Report available at: http://www.gao.gov/new.items/d06977t.pdf, Accessed: March 29, 2010.
From page 34...
... with increasing regulatory requirements aimed at assuring that the various types of devices are safe and effective before they are marketed9 -- Class I devices are classified as low risk, Class II devices as moderate risk, and Class III devices as high risk. The FDA generally considers laboratorydeveloped tests to be Class II devices.
From page 35...
... Vice Provost for Research Harvard University to do so. Moreover, a bill pending in the California State Senate would specifically exempt DTC genetic testing companies from CLIA.


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