By Dr. Jeffrey Shuren
FDA’s Center for Devices & Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access to medical devices that treat often life-threatening conditions. It’s also important for industry’s ability to continue developing new products.
While recent data suggest we’re making solid progress in bringing down total review times for both 510(k) submissions and our higher risk premarket approval applications, it’s always useful to get a reality check.
That’s why, as part of the 2012 Medical Device User Fee Amendments (MDUFA III), FDA agreed with the medical device industry to participate in an independent and comprehensive assessment of our review process.
A third party consulting firm assessed CDRH’s review process, management systems, IT infrastructure, workload management tools, reviewer training programs and staff turnover. Key findings were released in December 2013, along with a list of high-priority recommendations for improvements.
Their Final Report on Findings and Recommendations, released today, 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.
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.
After the December report came out, we put together our own plan of action to implement the high-priority recommendations. These recommendations call for:
- Developing criteria and establishing mechanisms to improve consistency in decision-making throughout the review process.
- Providing mandatory full staff training for the three primary IT systems that support MDUFA III reviews.
- Identifying metrics and incorporating methods to better assess review process training satisfaction, learning and staff behavior changes.
- Adopting a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews. This approach addresses such topics as corrective and preventive action and continuous process improvement, resource management, document management and system evaluation.
This action plan, also out today, has been divided into two stages. 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.
I encourage you to take a close look at the report and our plan of action. I think you’ll agree with me that sustained focus on these various management improvements will translate to more consistent and efficient reviews, advanced innovation and ultimately improved patient health.
Dr. Jeffrey Shuren is director of the FDA’s Center for Devices & Radiological Health.