FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.” This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review. It...Read More
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.
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