By Jof Enriquez, Follow me on Twitter @jofenriq
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has announced a new training program for its medical device staff to help them become more consistent and competent in the conduct of regulatory and premarket reviews. FDA is inviting interested companies, academia, and clinical facilities to participate in the 2015 Experiential Learning Program (ELP) General Training Program, wherein FDA staff will observe operations at participating facilities that have satisfactory compliance records with the agency.
"This training component 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,” states the FDA's notice in the Federal Register. "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."
According to the CDRH, it seeks to understand current industry practices, innovative technologies, regulatory impacts, and regulatory needs of device manufacturers, and the ELP program is one such avenue to enhance communication between regulators and manufacturers. Furthermore, CDRH says that regular staff training is consistent with its mandate to ensure the safety and effectiveness of medical devices marketed in the United States.
The program also is in line with FDA's push for higher product and manufacturing quality – through its Case for Quality (CfQ) initiative – which is a collaboration with device companies, patients, academia, government offices, and payers/providers.
"Through the CfQ, we are collaborating with internal and external customers to identify characteristics that are critical to the quality of a particular device. This will result in a shared understanding of product features and manufacturing processes most important to patient safety," states an FDA blog post.
The new training program will have eight new focus areas for device reviewers, according to RAPS.
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