FDA Digital Health Innovation Action Plan

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program.

Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.

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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