Planned CDRH Reorganization Will Impact Device Approvals and Inspections

At the FDA/Xavier MedCon Conference (May 1-4, 2018), CDRH Office of Compliance Regulatory Affairs Deputy Director Captain Sean Boyd will present the proposed reorganization plan that will collapse the Center’s seven offices into four, combining silos of expertise into a new office that aligns talent into teams by product type and technology. Individuals from the evaluation and compliance groups for specific product types and technologies will be on one team, creating a new review and inspection dynamic.

Engage with FDA and Industry Experts at MedCon on topics such as: 

  • EU MDR Changes
  • FDA Rethinks Handling of Corrections & Removals, Allegations, and 483 Responses
  • FDA's Digital Health Pre-Certification Program
  • Streamlining the PMA Process
  • Benefit/Risk
  • Investigator Insights