As part of the ongoing process begun by the 2012 Medical Device User Fee Amendments (MDUFA III),FDA has released its Implementation Plan for Priority Recommendations. This plan is intended to improve the efficiency of the device submission review process at the Center For Devices and Radiological Health (CDRH).
At the commencement of this process, FDA agreed to participate with the medical device industry in a comprehensive assessment of the process for device submission review. The consulting firm Booz Allen Hamilton was engaged to conduct the review.
In December 2013 the consultants issued their key findings along with a list of high-priority recommendations for improvements. This report identified four priority recommendations for FDA to improve the efficiency and review times of the medical device submission review process.
FDA's just-released plan is the agency's response and plan of action to address the issues found in the December report. Meanwhile, the consulting firm has released its Final Report on Findings and Recommendations, also on June 12.
One of the primary goals of CDRH's Implementation Plan is "to improve consistency in decision-making throughout the review process." The Center also intends to adopt "a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews." The document explains that, "(t)his approach addresses such topics as corrective and preventive action and continuous process improvement, resource management, document management and system evaluation."
According to Jeffrey Shuren, MD, director of the CDRH, "The report affirms that CDRH is on a path to meeting many of the challenges that were flagged in the months leading up to the enactment of MDUFA III, including such topics as sponsor communication, IT infrastructure, reviewer training, reviewer attrition, and submission quality."
Shuren continued, writing on the FDA Voice blog, "Initially, the contractor identified 31 unique issues related to the device submission review process. They concluded that CDRH had taken steps to address 21 of those 31 issues – either through the development and implementation of new MDUFA III provisions, updated systems, and/or processes for review staff – and that we had at least begun to address another nine of the issues. Only one issue – creating the tools and metrics to assess the consistency of decision-making across the program – remained. It was the driver for one of the contractor's high-priority recommendations."
FDA's Action Plan is divided into two stages. Shuren explains, "The first stage includes those actions needed to address specific recommendations identified in the December report, most of which will be implemented by 2016. The second stage covers longer-term actions to further enhance the efficiency of our processes beyond what the contractor recommended. We will now begin to execute this action plan. In addition, as we committed to do under MDUFA III, we will now develop an implementation plan for the new recommendations in this final report."
