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Entreprise · 15/10/20141 min de lecture
Distinguishing Medical Device Recalls From Medical Device Enhancements; Guidance for Industry and Food and Drug Administration Staff; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, "Distinguishing Medical Device Recalls From Medical Device Enhancements." This guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →