Tag Archives: CDRH

CDRH Issues Draft Guidance Regarding Test Reports for Nonclinical Bench Studies in Premarket Submissions

By Allyson B. Mullen — On May 31, 2018, CDRH issued the draft guidance, “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.” The draft guidance is intended to provide an outline of … Continue reading

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Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day Workshop

By Véronique Li * & Jeffrey K. Shapiro — The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and … Continue reading

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CDRH Issues New Draft Least Burdensome Guidance

By Allyson B. Mullen — Section 513 of the Federal Food, Drug, and Cosmetic Act requires FDA to consider the least burdensome means of evaluating device safety and effectiveness for Class III devices and substantial equivalence for devices requiring 510(k) … Continue reading

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