Distinguishing Medical Device Recalls From Medical Device Enhancements; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

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.