Tag Archives: CDRH

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

Posted in Products Liability | Tagged , , , , , , , , , , , | Leave a comment

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

Posted in Products Liability | Tagged , , , , , | Leave a comment