CDRH Invites Submissions for Its Experiential Learning Program

Manufacturers can now submit proposals to participate in the Center for Devices and Radiological Health’s (CDRH’s) Experiential Learning Program (ELP), an on-site or virtual visit program that gives CDRH staff an opportunity to better understand the device development life cycle.

Rather than performing regulatory activities, the CDRH review staff get to know the manufacturers’ quality management, manufacturing practices and issues that affect device development – including patient engagement.

CDRH says it wants to know how those involved in the medical device lifecycle incorporate patient input into various phases of the process. The phases may include discovery and ideation, invention and prototyping, preclinical testing, premarket clinical testing, product launch and postmarket activities.

The submission period opened on Feb. 1 and ends at noon on March 7. Device developers and other stakeholders are encouraged to include both on-site and virtual site proposals and to address patient engagement as a supplemental topic.