FDA News

FDA to improve device review procedures

In an effort to expedite the availability of new medical devices, the FDA’s Center for Devices and Radiological Health has undertaken an independent evaluation of its review process, the agency said in a press release.

In the evaluation — part of the 2012 Medical Device User Fee Amendments (MDUFA III) — the Center for Devices and Radiological Health (CDRH) engaged a third-party consulting firm to analyze the CDRH’s review process, management systems, IT organization, workload management methods, reviewer training and staff turnover.

The results were released in December 2013 and accompanied by a list of key recommendations for improvements. The Final Report on Findings and Recommendations, which was released this week, acknowledges that the CDRH has made meaningful efforts toward addressing 21 of the 31 identified issues. Additionally, the report found that the CDRH has begun to address nine additional recommendations. The only issue remaining is “creating the tools and metrics to assess the consistency of decision-making across the program,” the CDRH said in the release.

The following recommendations were released by Booz Allen Hamilton, the consulting firm hired to conduct the analysis:

  • develop criteria and establish mechanisms to improve consistency in decision-making throughout the review process
  • conduct mandatory full staff training for the three primary IT systems utilized for MDUFA III reviews
  • establish measures and implement methods to better evaluate review process training satisfaction, retention and subsequent changes in staff behavior
  • develop a holistic, multifaceted approach toward addressing five quality component areas to improve consistency of reviews. This includes:
  1. Senior Management: establish improved methods of communication, documentation and accountability
  2. Corrective and Preventive Action (CAPA) and Continuous Process Improvement (CPI): establish an official protocol for the logging, prioritization, monitoring, communication, and feedback provision for suggesting improvements and discussing non-CAPA matters
  3. Resource Management: utilize formal, regular training on new review methods for purposes of standardization, and evaluate understanding and behavioral changes through quantitative measurements
  4. Document Management: utilize an enhanced document control system, such as CTS, DocMan, Image 2000+ or SharePoint, with a focus on optimizing the usefulness of system changes to all staff
  5. System Evaluation: develop internal measures to track the quality and effectiveness of review processes and strive for ongoing process improvement

In response to these recommendations, the FDA has outlined a two-stage action plan for addressing each concern. The agency wrote that it plans to implement all Stage 1 actions by Dec. 31, 2015. Stage 1 initiatives specifically will address the recommendations, while Stage 2 actions will be broader and seek to advance these goals beyond the stated recommendations.

“Recognizing that the recommendations can be expanded to further enhance the efficiency of our processes, we also outline additional long-term actions CDRH intends to implement to further enhance the review process,” the FDA wrote in the action plan.

In an effort to expedite the availability of new medical devices, the FDA’s Center for Devices and Radiological Health has undertaken an independent evaluation of its review process, the agency said in a press release.

In the evaluation — part of the 2012 Medical Device User Fee Amendments (MDUFA III) — the Center for Devices and Radiological Health (CDRH) engaged a third-party consulting firm to analyze the CDRH’s review process, management systems, IT organization, workload management methods, reviewer training and staff turnover.

The results were released in December 2013 and accompanied by a list of key recommendations for improvements. The Final Report on Findings and Recommendations, which was released this week, acknowledges that the CDRH has made meaningful efforts toward addressing 21 of the 31 identified issues. Additionally, the report found that the CDRH has begun to address nine additional recommendations. The only issue remaining is “creating the tools and metrics to assess the consistency of decision-making across the program,” the CDRH said in the release.

The following recommendations were released by Booz Allen Hamilton, the consulting firm hired to conduct the analysis:

  • develop criteria and establish mechanisms to improve consistency in decision-making throughout the review process
  • conduct mandatory full staff training for the three primary IT systems utilized for MDUFA III reviews
  • establish measures and implement methods to better evaluate review process training satisfaction, retention and subsequent changes in staff behavior
  • develop a holistic, multifaceted approach toward addressing five quality component areas to improve consistency of reviews. This includes:
  1. Senior Management: establish improved methods of communication, documentation and accountability
  2. Corrective and Preventive Action (CAPA) and Continuous Process Improvement (CPI): establish an official protocol for the logging, prioritization, monitoring, communication, and feedback provision for suggesting improvements and discussing non-CAPA matters
  3. Resource Management: utilize formal, regular training on new review methods for purposes of standardization, and evaluate understanding and behavioral changes through quantitative measurements
  4. Document Management: utilize an enhanced document control system, such as CTS, DocMan, Image 2000+ or SharePoint, with a focus on optimizing the usefulness of system changes to all staff
  5. System Evaluation: develop internal measures to track the quality and effectiveness of review processes and strive for ongoing process improvement

In response to these recommendations, the FDA has outlined a two-stage action plan for addressing each concern. The agency wrote that it plans to implement all Stage 1 actions by Dec. 31, 2015. Stage 1 initiatives specifically will address the recommendations, while Stage 2 actions will be broader and seek to advance these goals beyond the stated recommendations.

“Recognizing that the recommendations can be expanded to further enhance the efficiency of our processes, we also outline additional long-term actions CDRH intends to implement to further enhance the review process,” the FDA wrote in the action plan.