Understanding the CDRH Reorganization and Its Potential Impact on Premarket Submission Reviews: Frequently Asked Questions & What You Need to Know

Understanding the CDRH Reorganization and Its Potential Impact on Premarket Submission Reviews: Frequently Asked Questions & What You Need to Know

By: Samie Allen, MBA and Joshua Crist, MSE

Overview

It can be hard to keep up with the rapid pace of changes in FDA’s regulations and review policies for medical devices. One area that changes roughly every 5 years in some capacity is the organizational structure of the Center for Devices and Radiological Health (CDRH). However, the new reorganization that CDRH is piloting is by far the largest in +30 years. With this ongoing restructuring and more change on the horizon, it is important to understand how the device premarket review process may be impacted.

In this paper, consultants from Biologics Consulting’s Medical Device Specialty Group, Samie Allen, MBA and Joshua Crist, MSE, will provide expert insight on:

  • The ongoing OPEQ pilot for implementing reorganization
  • The new organizational structure planned for CDRH
  • How ODE, OC, and OSB are being merged
  • How the OPEQ reorganization impacts the premarket review process.

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About the Authors

Samie Allen, MBA is a senior consultant on Biologics Consulting’s Medical Device Specialty Group. Prior to joining the Biologics Consulting team, she spent over 24 years with the Food and Drug Administration; 23 of those years were spent at the Center for Devices and Radiological Health (CDRH) and most recently she was a Policy Analyst in the Office of Device Evaluation (ODE). Samie’s cross-cutting FDA experience allows her to provide clients with a specialized understanding of regulatory processes for devices. Read More >

 

 

Mr. Crist joined Biologics Consulting in 2018 with 7 years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. His experience includes review of IDEs, 510k(s), De Novos, PMAs, HDEs, Q-Submissions (Pre-Submissions), and Expedited Access Pathway (EAP) submissions. Read More