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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”. The FDA webinar information can be found here.

Patients

Patients Clinic Medical Patient-Centered

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. By Andrew J. Such a message may understandably deter the targeted conduct to avoid such a risk. The memo also instructs U.S.

Manufacturing

Manufacturing Provider Medical IT

Primary Care Digest

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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