Dive Brief:
-
The FDA’s Center for Devices and Radiological Health announced in a July 24 notice that their staff training Experiential Learning Program, intended to keep staff up to date on challenges and issues that influence the product cycle of medical devices, is extending into 2019.
-
The agency is inviting medical device industry, academic parties and healthcare facilities to participate in the collaborative training to facilitate the premarket review process.
-
Groups of CDRH and other FDA staff "will observe operations in the areas of research, device development, Digital Health, incorporating patient information and reimbursement, manufacturing, quality management principles, and health care facilities," according to the notice.
Dive Insight:
The program was implemented in 2013 to provide ongoing training to FDA staff on the total product life cycle of medical devices, issues faced at each step, laboratory practices and more, through on-site visits and presentations.
The FDA said the extension is an effort to streamline regulatory pathways with the input of outside stakeholders.
The effort is focused on reviewing the device development cycle. In 2016 and 2017 it prioritized dual goals of “Partnering with Patients” and “Promoting a Culture of Quality and Organizational Excellence.”
Moving forward, their 2018 to 2020 focus adds “Simplicity, Collaborative Communities and Employee Engagement, Opportunity, and Success,” along with their previous patient- and quality-centered commitments.
The program extension comes on the tail of a series of recent FDA policy commitments in the medical device space and federal desire for outside perspective.
Probable areas of focus for ELP training moving into 2019 include quality system management, process simplification, patient perspectives and laboratory procedures.