FDA Distinguishing Recalls from Enhancements Draft

The FDA published a draft guidance on Medical Device Reporting for Manufacturing on Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements – Draft Guidance for Industry and Food and Drug Administration Staff. This guidance is structured as a series of questions and answers and is at the link provided.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.