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Negocios · 3/5/20011 min de lectura
Medical Devices: Draft “The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles;” Availability
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Resumen
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles." In this draft guidance, FDA sets forth its interpretation of the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) that require FDA to take into account the least burdensome means for applicants to demonstrate a device's effectiveness or substantial equivalence. This guidance is neither final nor is it in effect at this time.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →