Regulatory News - Report on FDA Device Review Process

As part of FDA’s Performance Goals and Procedures adopted under MDUFA III (The Medical Device User Fee Act of 2012), the FDA agreed to participate with the medical device industry in an independent assessment of the process for the review of medical device submissions. The key objective of this task was to develop a set of recommendations for FDA to implement with the potential to have a significant impact on review times. The recently released report, prepared by Booz Allen, identifies four broad areas where the agency should improve its methods for premarket review of medical devices:

• Establishing criteria to develop more consistent decision making in the course of market authorization reviews. Industry stakeholders reported inconsistencies between reviewers referencing outdated guidance during submission reviews, as well as reviewers referencing new standards that were not yet released at the time of original submission. Regularly occurring meetings between Lead Reviewers and Master Reviewers within review branches could be convened to develop a standard working list of criteria for decision making (e.g., within a review branch) that may evolve as technological advancements occur.
• Mandatory full staff training on all three major IT systems used for MDUFA III reviews: DocMan is a repository that enables collaborative review by review staff and contains communications between FDA and applicants; Image2000+ serves as the repository for all official and finalized documents at CDRH; CTS serves as CDRH’s central document tracking tool for premarket submissions. From the perspective of Lead Reviewers, IT training had a significant positive effect on facilitating more efficient reviews.
• Using appropriate metrics to effectively assess training and learning of staff. Analysis of four training programs uncovered gaps in FDA’s ability to objectively assess the impact of learning and the extent to which participants’ review behaviors changed as a result of training. Post-training surveys and/or interviews regarding participants’ experience with integrating the knowledge learned can serve as a valuable resource in validating training or identifying a need for change
• Standardizing process lifecycle management processes for more consistent reviews

• Senior Management: Document and communicate a mechanism for issue accountability and follow-up
• Resource Management: Deploy formal, regularly-scheduled training on new review processes to standardize awareness. Use quantitative methods to assess understanding and activation of behavioral changes
• Document Management: Deploy planned document control system enhancements (e.g., CTS, DocMan, Image2000+, SharePoint) using a quality-oriented focus to optimize the utility of system changes to all review staff
• Corrective and Preventive Action (CAPA) and Continuous Process Improvement (CPI): Develop a more formal method for logging, prioritizing, tracking, communicating and providing feedback on non-CAPA issues and improvement ideas. The review found that the Office of Device Evaluation has implemented a CAPA database to resolve issues that impact multiple Divisions. However, for non-CAPA (i.e., Division-specific) issues, there is currently no formal method to log, track, or prioritize issues, or communicate feedback.
• Identify and develop internal metrics to monitor the quality and effectiveness of review processes and facilitate continuous process improvement Program operations staff have noticed that for several submissions that did not meet their MDUFA goal dates, milestones were missed earlier in the process. As a result, program operations staff now pay more attention to these indicators and send reminders to Lead Reviewers of upcoming due dates. While this mechanism may work to identify some submissions at risk for longer review times, more internal metrics are needed to ensure the quality and effectiveness of the review process. The report recommends that CDRH identify internal metrics to support the monitoring process and facilitate continuous process improvement

These are the priority recommendations that are considered to have the greatest impact on the efficiency of the review process. The evaluation is continuing and a final report with recommendations is expected in late 2014.