The US Food and Drug Administration (FDA) has introduced a new
training program for staff reviewing Premarket Applications at the
agency’s 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, launches this month and will be
required for all new device reviewers. The program includes up to 18
months of training to sharpen staff skills and knowledge in areas such
as biomedical engineering and healthcare. "This investment will improve
the quality of submission review and make the process more consistent
and predictable," said CDRH Director Jeffrey Shuren.
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