CDRH Invites Participants For Experiential Learning Program

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is inviting participants from medical device companies, academia, clinical facilities, research organizations, medical device incubators, and other stakeholders to participate in the center's Experiential Learning Program (ELP), a collaborative effort with industry to facilitate the premarket review process.

Started in 2012, ELP is a training program for FDA review staff who visit industry partner facilities to gain a better understanding of how medical devices are designed, tested, manufactured, used, and impact patient care. The program also is meant to orient participants to emerging device technologies, and to give them a better insight on how to perform pre-market reviews of resulting medical devices that feature these innovative technologies.

"These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff a better understanding of the products they review, how they are developed, the voice of the patient, challenges related to quality systems development and management in the product life cycle, and how medical devices fit into the larger healthcare system," FDA stated in an announcement.

For this year, CDRH encourages partner institutions and companies to provide FDA staff insight on how they implement two strategic priorities – Partnering with Patients and Promoting a Culture of Quality and Organizational Excellence – to the device development lifecycle.

CDRH says 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, as well as how the performance of marketed devices is monitored.

According to RAPS, on a quarterly basis, CDRH will update a table of training needs displaying main areas of interest for staff visits, which include: biocompatibility, combination products, clinical trials, digital health/software, import shipping facilities, in vitro diagnostics, manufacturing, postmarket assessment, quality management, reprocessing and sterilization, standards conformity assessment testing, and innovation.

Applicants can submit ELP proposals containing their preferred area/s of interest and other details until April 30, 2017. Instructions for the submission process are listed in the Federal Register notice.