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.
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).
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