On Wednesday, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health took to the agency’s official blog to update the industry on how the improvement of the medical devices review process is going.
A lack of consistency in the device submissions and review process, coupled with reviewer turnover, among other things have been the source of much ire and angst among medical device industry professionals in recent years.
The process dates back to the 2012 user fee negotiations with industry when CDRH agreed to an independent review of its processes. Consulting firm Booz Allen Hamilton evaluated CDRH’s review process, management systems, IT infrastructure, workload management tools, reviewer training programs and staff turnover. And in December provided four major recommendations that would overhaul :
- Develop criteria and establish mechanisms to improve consistency in decision making throughout the review process.
- Provide mandatory full staff training for the three primary IT systems that support MDUFA III reviews.
- Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes.
- Adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews.
On Wednesday, the agency released the final report from Booz, as Shuren provided details of an implementation plan that would put those recommendations to practice. For instance, in regard to the first recommendation, CDRH in Stage 1 of the implementation plan aims to "inventory and, as needed, develop business process maps for 510(k) clearance decisions, PMA approval decisions, 510(k) requests for Additional Information, PMA Major Deficiencies, and IDE approval decisions." The same stage will also lead to "gap analysis" study to "identify needed key processes, procedures, policies, IT, and metrics" associated with different types of device review processes.
For the second Booz recommendation, CDRH expects to inventory the Center Tracking System (CTS), Document Management (DocMan), and Image2000+ training available to CDRH staff as well as identify the staff that requires training on these. In Stage 1 of the implementation plan, CDRH also expects to create a group of experts in these IT systems to provide further support to staff reviewers.
For the third recommendation, the Center aims to "research best practices for training evaluation in similar organizations" and develop a premarket review training evaluation that would include Staff College, Offices, Divisions and others in Stage 1 of the implementation plan.
For the fourth and final recommendation, CDRH aims to conduct a gap analysis to "assess what is needed to improve current premarket CAPA (Corrective and Preventive Action) and management review business processes among other things in Stage i of the plan. The Center also aims to "implement changes to existing infrastructure to support the established procedures for logging, prioritizing, tracking, communicating and providing feedback on CAPA, non-CAPA issues, and improvement ideas for premarket review processes, including new processes.
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