FDA Releases Plan to Improve Device Review Procedures

The U.S. Food and Drug Administration (FDA) has released a detailed plan to improve medical device review procedures within the Center for Devices and Radiological Health (CDRH) based on recommendations from an outside auditor’s report issued late last year.

The FDA intends to implement a two-stage process to address four major recommendations of a report released by consultants Booz Allen Hamilton in December 2013. To meet those recommendations,the firm advised the FDA to establish more consistency in decision-making, ramp up its training programs and address quality management issues to make the review process more transparent and standardized for reviewers and the companies undergoing review.

“A recurring issue that was identified during our analyses was inconsistent decision-making throughout various stages of the review process, in particular a lack of transparency in thresholds or requirements used to trigger AI (additional information) requests,” Booz Allen’s report states. “In addition, industry stakeholders reported inconsistencies between reviewers referencing outdated guidance during submission reviews, as well as reviewers referencing new standards that were not yet finalized at the time of original submission. Development of tools, criteria and/or mechanisms for assessing and ensuring the consistency of review processes would help ameliorate this issue.”

Booz Allen initially identified 31 “unique” issues related to the device submission review process. The consulting firm concluded that CDRH officials had taken steps to address 21 of those 31 issues, either through the development and implementation of new Medical Device User Fee Amendment III provisions, updated systems, and/or processes for review staff –- and that the division had 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, and it was the driver for one of the contractor’s high-priority recommendations, CDRHDirector Dr. Jeffrey Shuren said in a blog last week.

After the December report came out, the CDRH put together its own plan to implement the Booz Allen recommendations. Its strategy calls for:

• — Developing criteria and establishing mechanisms to improve consistency in decision-making throughout the review process;
• — Identifying metrics and incorporating methods to better assess review process training satisfaction, learning and staff behavior changes; and
• — 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.

The action plan is divided into two stages. The first 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,”Shuren wrote in the blog.

The Advanced Medical Technology Association (AdvaMed) commended the FDA for drafting a detailed plan to implement Booz Allen’s recommendations and said it will particularly monitor the CDRH’s progress on optimizings the center’s refuse-to-accept (RTA) process.

“An increasing number of 510(k) submissions are being denied by the agency under this process, and we believe it could benefit from more consistent implementation by FDA as well as additional information to sponsors on the administrative requirements for 510(k)s,” Janet Trunzo, senior executive vice president, technology and regulatory affairs, for AdvaMed, said in a prepared statement. “While AdvaMed is still reviewing the details of the BAH report, we are pleased that the report’s recommendations support the association’s long-held priorities on the need to improve the consistency in decision-making throughout FDA’s review process and to enhance reviewer training and management oversight within the agency’s device center.”

“Of the seven new recommendations in BAH’s report, AdvaMed is particularly supportive of the proposal to analyze the root-cause of withdrawn submissions and to develop mechanisms to reduce their occurrence. While we have seen some improvement in total review times in recent years, the percentage of withdrawn submissions remains unacceptably high,” Trunzo concluded.