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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

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

Patients

Patients Clinic Medical Patient-Centered

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

OCTOBER 10, 2023

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

Manufacturing

Manufacturing Engineering Clinic Provider

Webinars

How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

MORE WEBINARS

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

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Webinars

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