The CDRH Reorganization - Webinar Recording/Transcript

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The CDRH Reorganization: Managing Total Product Life Cycle, Real World Evidence, and Digital Health Policies

Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization.

After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements.

It behooves you to understand the new structure and how it will affect you.

Paul Gadiock Esq., formerly Associate Director for Policy at the CDRH and now a Senior Attorney at Arent Fox LLP, shares insider knowledge in a session that’s a must for every FDA-regulated devicemaker. Here’s what you’ll learn:

  • The right office to contact after the reorganization — not too high, not too low
  • The right way to frame your case: Making the most persuasive argument.
  • The background: Lessons learned from similar reorganizations at CDER and CDRH/OIR
  • How CDRH regulatory policies, such as the TPLC, Real World Evidence and Digital Heath, influenced the CDRH reorganization
  • Impact of current high-level Center vacancies
  • How reorganization may affect CDRH interplay with other FDA bureaus
  • And much more!

The CDRH enforces the rules you live under. Knowing who to contact post-reorganization, and best ways to make your case, is priceless information. It’s well worth 90 minutes of your time to get an advance look at this fundamental change to your regulatory landscape.

This session is aimed squarely at the regenerative medicine community, including job responsibilities such as:

  • Executive suite
  • Doctors
  • Other caregivers
  • Researchers
  • Regulatory affairs/compliance
  • Legal counsel
  • Business development
  • Marketing/sales

Paul Gadiock Esq., Senior Attorney at Arent Fox LLP, spent nearly 10 years inside the CDRH, most recently as Associate Center Director for Policy.