FDA’s Center for Devices and Radiological Health (CDRH) has announced its 2016 Experiential Learning Program (ELP), and is inviting applicable parties (e.g., medical device industry, academia, and health care facilities) interested in contributing, to submit a request for participation.
Background
According to FDA, ELP provides “a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.” FDA states that “the ELP is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle.” ELP does this by allowing CDRH staff to gain real-world experience, gaining knowledge from the medical device industry, the clinical community, and academic stakeholders, to improve the pre-market review process.
CDRH launched the ELP pilot program in 2012 as one of its initiatives to enhance the performance of staff involved in the regulatory and premarket review process. The program was fully implemented on April 2, 2013.
2016 ELP
As part of the formal training program, groups of CDRH staff will observe operations at research, academia, and health care facilities. Furthermore, CDRH is placing a focus on a number of specific areas including, but not limited to, usability testing and reprocessing and reuse of single-use devices (SUDs).
*A full list of CDRH’s specific areas of interest is available in the FDA’s Federal Register notice.
“FDA is formally requesting participation from companies, academia, and clinical facilities, including those that have previously participated in the ELP or other FDA site visit programs.” Applicable and interested parties should submit requests for participation by April 11th.