mdi Consultants
CDRH offers an innovative learning opportunity for new and experienced review staff. The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices. Because technology continuously evolves, it is essential that CDRH review staff members are aware of and understands how medical devices are developed, clinically tested, manufactured, and used. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle.
In this training program, groups of CDRH staff will observe operations in the areas of research, device development, in making coverage decisions and assessments, incorporating patient information and reimbursement, manufacturing, academia, and health care facilities. The areas of interest for visits include various topics identified by managers at CDRH. These areas of interest are listed publicly and are intended to be updated quarterly. CDRH will be responsible for CDRH staff travel expenses associated with the site visits. CDRH will not provide funds to support the training provided by the site to the ELP. Selection of potential facilities will be based on CDRH’s priorities for staff training and resources available to fund this program
A Federal Register (FR) Notice was published on March 23, 2017 and will remain open until September 30, 2017; and describes the ELP, incorporating broader training areas, as well as the application and proposal submission process. The Federal Register Notice can be found at:
https://www.federalregister.gov/documents/2017/03/23/2017-05763/center-for-devices-and-radiological-health-experiential-learning-program?source=govdelivery&utm_medium=email&utm_source=govdelivery
“Submit either electronic or written requests for participation in the ELP by “Submission Period: March 23, 2017- April 30, 2017” in the ELP Web site at
https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
If you have questions about the FR Notice or the ELP Program, please contact: Christian R. Hussong, CDRH/OCE Division of Employee Training and Development via email or phone (240) 402-2246.
? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form.