Docket: Industry Comments Part 11 Draft Guidances

Industry comments sent to FDA on the Draft Part 11 Guidances are posted 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:

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