Are Current Regulations for Approval of In Vitro Diagnostic Devices Adequate?
Article Abstract:
FDA regulations for approving diagnostic reagents and tests are not adequate to protect the public. Many diagnostic devices do not require extensive testing but simply need to be shown to be equivalent to existing devices. Once a device is on the market, it may be very difficult to take it off the market. One test still in use, an Epstein-Barr virus test, has an 83% false-positive rate. Many reports are published about the accuracy of various tests, but the FDA staff may not be able to comprehensively review this literature.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
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Are Current Regulations for Approval of In Vitro Diagnostic Devices Adequate?
Article Abstract:
FDA regulations for approving diagnostic reagents and tests are not adequate to protect the public. Many diagnostic devices do not require extensive testing but simply need to be shown to be equivalent to existing devices. Once a device is on the market, it may be very difficult to take it off the market. One test still in use, an Epstein-Barr virus test, has an 83% false-positive rate. Many reports are published about the accuracy of various tests, but the FDA staff may not be able to comprehensively review this literature.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
User Contributions:
Comment about this article or add new information about this topic:
Update on FDA Regulation of In Vitro Diagnostic Devices
Article Abstract:
Scientists in the FDA's Office of Device Evaluation describe the process by which the agency regulates diagnostic reagents and tests. A staff of 45 scientists reviews about 1,000 premarket applications from device manufacturers annually. In 1993, the MedWatch system was introduced, which allows physicians to report problems with diagnostic tests. FDA staff can also learn of such problems by reviewing the medical literature. The agency can recall devices but prefers to work with manufacturers to resolve the problem.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
User Contributions:
Comment about this article or add new information about this topic:
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