FDA Announces Training Program to Improve Medical Device Reviews

The U.S. Food and Drug Administration (FDA) just announced two training programs it will be implementing that are intended to improve how medical device reviews are conducted.

The training will improve review consistency and will help improve the skills of the reviewers looking at premarket applications at the Center for Devices and Radiological Health (CDRH).

The Reviewer Certification Program began as a pilot in April 2010 and involved participants from CDRH’s Division of Anesthesia, General Hospital, and Infection Control, and Dental Devices. The live program will be implemented this month and is intended to include all new device reviewers.

Involving 18 months of training, the program has been designed to harmonize skills and knowledge brought to the CDRH by new reviewers who are coming from areas including biomedical engineering and health care.

The reviewers will complete training in a number of ways: Online training modules, instructor-led courses, and practical experience derived from the medical device review process. Medical devices, food and drug law, and regulatory requirements, the CDRH review process, device design, and human factor impact, are among the courses involved.

“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 Shuren, M.D. “This investment will improve the quality of submission review and make the process more consistent and predictable,” Dr. Shuren added.

The FDA said that the CDRH is also developing a pilot Experiential Learning Program for premarket reviewers that will include visits to academic institutions, manufacturers, research organizations, and health care facilities and is also intended to provide reviewers a better understanding of how medical devices are designed, manufactured, and used. The intricacies of the technology department and how medical devices impact patient care will also be covered. This program is in the design stage and should be introduced as a pilot program in 2012.

“Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices,” Dr. Shuren said.

Enhancing staff training is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations that were announced this year. The Plan is meant to increase the predictability and transparency of regulatory pathways and strengthen the 510(k) process, the most common pathway to market for medical devices.

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