CDRH Provides Update on Improving the Medical Device Review Process

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) has released a final implementation plan that details actions the agency intends to take to improve the efficiency and review times of medical device submissions.

In an update to a plan released in June, the CDRH details what actions it will take in response to 11 recommendations made by Booz Allen Hamilton (BAH), an independent contractor, in a June 2014 report. The recommendations are the following:
• Adopt a holistic, multipronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews.
• Develop criteria and establish mechanisms to improve consistency in decision making throughout the review process.
• Optimize the refuse-to-accept process by improving awareness of and clarity around the administrative requirements for 510(k) submissions.
• Perform a retrospective root cause analysis of withdrawn submissions and develop a mechanism to minimize their occurrence.
• Implement a consistent practice for communicating early and frequently with sponsors during the substantive review phase to address and resolve potential issues prior to substantive interaction.
• Provide mandatory full-staff training for the three primary information technology systems that support Medical Device User Fee Amendments of 2012 (MDUFA III) reviews.
• Provide increased clarity to applicants beyond existing eCopy guidance to enhance organized submission structure.
• Evaluate tools for providing a comprehensive view of staff workload.
• Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes.
• Promote informal training and knowledge sharing by seasoned staff for review staff and management to share division- or science-specific review processes, lessons learned, and best practices.
• Develop CDRH-wide staff transition and succession plans to mitigate the impact of turnover on submission reviews.

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Source: AAMI