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 effective digital health products. One step in the plan is developing a Digital Health Software Precertification (Pre-Cert) Program. We blogged on the overall digital health plan here. As part of developing the Pre‑Cert Program, Dr. Jeff Shuren, Center Director of CDRH, welcomed the audience to a two day workshop at the end of January. Bakul Patel, Associate Director for Digital Health, introduced the program in detail, summarizing its progress to date and sharing lessons learned. The workshop was divided into five panels with opportunities for the audience to ask questions on the first day and three breakout sessions with time to share breakout discussions with the larger group on the second day. The panels included…

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