The Center for Devices and Radiological Health (CDRH) announced the 2017 Experiential Learning Program (ELP), which aims to provide CDRH staff an opportunity to understand challenges that impact the device development life cycle.
The formal training visits by CDRH staff under the program are not intended for the FDA to inspect, assess, judge, or perform a regulatory function, the agency said.
CDRH is inviting participation from companies, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups and others, including those that have previously participated in the ELP or other FDA site visit programs.
All sites that participate in the ELP program must have a successful compliance record with the FDA or another agency with which the FDA has a memorandum of understanding. — Cynthia Jessup