Aiming to streamline its reviews of new medical devices, the FDA will roll out two new training programs for product reviewers. The agency, in its Sept. 6 announcement of the programs, stated that the programs will improve the review process by “enhancing the skills of those reviewing premarket applications” at the Center for Devices and Radiological Health (CDRH).
The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, will launch this month. It is intended to involve all reviewers of new devices, according to a release.
Online, instructor-led and hands-on courses will cover material on medical devices, food and drug law and regulatory requirements, the CDRH review process, device design and the impact of human factors. Course content will draw from multiple disciplines, including biomedical engineering.
“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” said CDRH Director Jeffrey E. Shuren, MD. “This investment will improve the quality of submission review and make the process more consistent and predictable.”