SILVER SPRING, Md., Sept. 6, 2011--The U.S. Food and Drug Administration today announced two new training
programs designed to improve the consistency of medical device reviews
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 and is
intended to include all new device reviewers.
The program includes up to 18 months of training, aimed at complementing
the skills and knowledge that new reviewers bring to CDRH from fields
such as biomedical engineering and health care. Reviewers in the program
will complete online training modules, instructor-led courses, and
obtain practical experience in the medical device review process.
Courses include medical devices, food and drug law and regulatory
requirements, the CDRH review process, device design, and the impact of
human factors.
"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."
CDRH is also developing a pilot Experiential Learning Program for
premarket reviewers. The program will include visits to academic
institutions, manufacturers, research organizations, and health care
facilities and is intended to give reviewers a better understanding of
how medical devices are designed, manufactured and used. The program
will also help new medical device reviewers understand the challenges of
technology development and the impact of medical devices on patient
care.
"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," Shuren said.
The Experiential Learning Program is in the design stage and scheduled to begin as a pilot program in 2012.
Enhancing staff training is one of the 25 action items listed in the
FDA's Plan of Action for Implementation of 510(k) and Science
Recommendations announced earlier this year to increase the
predictability and transparency of regulatory pathways and to strengthen
the 510(k) process. The 510(k) is the most common pathway to market for
medical devices.
For more information:
CDRH Plan of Action for 510(k) and Science
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation's food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
