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Are Current Regulations for Approval of In Vitro Diagnostic Devices Adequate?
Dorothy Levine, MD;
Richard Grossberg, MD;
Richard Tilton, PhD;
Peter Banks, MD;
Alvin Rosenfeld, MD
JAMA. 1998;280:187-189.
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IN VITRO DIAGNOSTIC products are reagents and instruments that medical personnel and private citizens use to diagnose disease or other health-related conditions. No test can yield perfect results, but when used properly, a test's false-negative and false-positive rates should be minimal (D. B. Burlington, oral communication [testimony before the US House of Representatives' subcommittee on Oversight and Investigations Committee on Commerce], September 1996). Although contemporary in vitro diagnostic tests are assumed to provide valid and clinically meaningful results, many have not been subjected to rigorous scientific evaluation. Current regulations are inadequate to ensure that only clinically useful products reach and remain on the market.
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is responsible for ensuring that medical devices are effective. The CDRH sets manufacturing regulations and performance standards, monitors . . . [Full Text of this Article]
From New England Pediatrics, Limited Liability Partnership, Stamford, Conn (Drs Levine and Grossberg); BBI Clinical Laboratories, New Britain, Conn (Dr Tilton); Carolinas Medical Center, Charlotte, NC (Dr Banks); Dr Rosenfeld is a consulting adult and child psychiatrist in Greenwich, Conn.
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