July 17, 2019 — The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the 2020 Experiential Learning Program site visit proposal solicitation period. The 2020 Fall ELP submission period is open from Monday July 8, 2019 – Thursday, August 8, 2019, at 12 p.m. EST. The ELP is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing and healthcare facilities to observe how medical devices are designed, developed and utilized.
The program has expanded to provide FDA staff with opportunities to better understand policies, laboratory practices, patient input and quality system management. The ELP is a collaborative effort to enhance communication and facilitation of the medical device review process. CDRH said it is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices.
CDRH is inviting medical device companies, academia and healthcare facilities to participate in this formal training program. Details of the program can be found on the ELP website, which provides the background, current training needs and proposal submission process. The training needs will be updated twice a year, in February and July, with a solicitation period for stakeholders to submit training proposals.
For more information: www.fda.gov