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• Perform a retrospective root cause analysis of withdrawn submissions and develop a mechanism to minimize their occurrence.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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