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Regulatory News | 13 November 2015 | By Zachary Brennan
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia, and health care facilities to participate again in a program that helps train medical device review staff.
The 2015 Experiential Learning Program (ELP) General Training Program, which was first launched in September 2011, is intended to provide CDRH staff with a better understanding of the policies, laboratory practices and challenges of the device development life cycle.
"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," the agency said in a Federal Register notice. "Through this notice, CDRH 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."
The program, which was officially launched in April 2013 and later expanded, and then expanded again a year later to include 34 new areas of interest, much of which was linked to in vitro diagnostics and manufacturing technology.
Now the Office of Device Evaluation wants its review staff to hone in on eight new topics, including:
FDA says it will pay for the travel expenses for its employees to the sites, all of which "must have a successful compliance record with FDA or another agency with which FDA has a memorandum of understanding."
The agency also includes information on how to request to participate.
Federal Register Notice
Tags: CDRH, IVDs, medical device training, device manufacturing