Samie Allen, MBA

Samie Allen, MBA

Senior Consultant

Samie comes to Biologics Consulting with over 24 years of experience with the Food and Drug Administration, 23 of which were spent at the Center for Devices and Radiological Health (CDRH). Most recently, she was a Policy Analyst in the Office of Device Evaluation (ODE). The ODE is responsible for the review and approval of all medical devices in the U.S., with the exception of in vitro diagnostic and radiological devices. Samie served as the primary ODE liaison for IT and policy development for premarket submissions. Many of these IT and policy developments were in direct response to MDUFA negotiations and implementation of FDASIA. She also led the development and management of the CDRH eCopy Program.

Prior to her recent role as ODE Policy Analyst, Samie spent over 16 years as a biomedical engineer and lead reviewer in ODE. She reviewed orthopedic devices and plastic and reconstructive devices for many premarket submission types (e.g., 510(k)s, PMAs, IDEs). Samie’s other experience in CDRH includes the PMA Staff (including nearly one year as Acting PMA Staff Director) in ODE and lead of the Section 522 Postmarket Surveillance Program in the Office of Surveillance and Biometrics (OSB). Before circling back to ODE as a Policy Analyst, Samie took advantage of an opportunity to work at FDA’s new Center for Tobacco Products where she assisted in developing several programs from the ground up.

Samie’s cross-cutting FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency.

She holds a B.S. in Biomedical Engineering from Rensselaer Polytechnic Institute and a M.B.A. from Hood College.

As a Consultant for Medical Devices with Biologics Consulting, Samie will utilize her broad technical and regulatory expertise to assist clients in the following areas:

  • Preparing and assisting in the preparation of all types of regulatory submissions for medical devices, including 510(k)s, De Novos, Pre-IDEs (Q-Submissions), IDEs, PMAs, HDEs, and 513(g)s
  • Reviewing and submitting regulatory submissions
  • Representing clients in interactions with FDA
  • Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
  • Preparing or assisting in the preparation of eCopies that meet FDA requirements
  • Providing clients with a comprehensive "FDA style" review of submissions

Education

MBA, Hood College, Frederick, MD (1995)

BS, Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY (1989)

Electrical Engineering Coursework Rochester Institute of Technology, Rochester, NY (1985)