More Oversight Needed for LDTs

• Autores: Rebecca Voelker
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 315, Nº. 1, 2016, págs. 20-20
• Idioma: inglés
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• Resumen

  • The FDA made its case for greater regulatory authority over laboratory developed tests (LDTs) in a recent report that details 20 incidents in which the tests were linked with patient harm (http://1.usa.gov/1PL0iot).

    Laboratory developed tests are considered a subset of in vitro diagnostics, which the FDA has regulated as medical devices since 1976. In contrast to diagnostic tests made by a conventional manufacturer and used by many laboratories, LDTs are designed, manufactured, and used in a single laboratory.