SOCRA NYS Chapter Virtual Series: Expanding Access to Medical Device for Patients: Expanded Access Program and the Breakthrough Devices Program

July 17, 2020
Noon - 1:00 p.m.

Friday,  July 17, Noon – 1:00 p.m. EST

Expanding Access to Medical Device for Patients: Expanded Access Program and the Breakthrough Devices Program
Donna Headlee, BSN, RN, CCRP

The average time from medical device concept to marketing approval has been reported as three to seven years. If alternative treatments are not available, this is problematic for patients with serious or life-threatening diseases. Expanded access permits patients with life-threatening conditions who are not eligible to participate in clinical trials to receive investigational devices before formal product approval. This presentation will provide an overview of multiple programs at CDRH that enable patient access to important devices. This presentation will introduce the Expanded Access Program, and the Breakthrough Devices Program.

Speaker Bio:  Donna Headlee is the Premarket Programs Branch Chief, Division of Industry and Consumer Education (DICE), in CDRH's Office of Communication and Education. In this role, Ms. Headlee leads the branch in the development of medical device industry education on premarket resources. She joined FDA in 2004 as a Consumer Safety Officer with the Office of Compliance (OC), Division of Bioresearch Monitoring in the Special Investigations Branch. In 2009, she joined the Premarket Application (PMA) Section of the Program Operations Staff, in the Office of Device Evaluation. She joined DICE in February 2016.

 Prior to her FDA career, Ms. Headlee served as a Research Nurse Coordinator at the National Institute of Health (NIH), with the National Cancer Institute (NCI), where she served as a Research Coordinator for Phase 1 oncology clinical trials. Ms. Headlee received a Bachelor of Science Degree in Nursing from Salisbury State College and a Masters Certificate in Regulatory Compliance from Hood College.

This program is open to the public, anyone may attend this free Zoom session. 

 You must register to attend.  

Send registration request to:  Once registered, Zoom access information will be provided.

Please note when you register if you need a Certificate of Attendance – General (non-SOCRA member) or SOCRA Certificate (SOCRA member). Certificates of Attendance are often used for career development and recertification requirements (such as if you are certified through SOCRA, ACRP, RAPs, etc.)

 *SOCRA continuing education approved for 1 hour for this program.  SOCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

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