Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements." This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. This draft guidance is not final nor is it in effect at this time.