By Stewart Eisenhart, Emergo Group
Following third-party process improvement recommendations issued in late 2013, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has laid out a two-stage plan to implement those changes for medical device reviews.
The recommendations from Booz Allen Hamilton focused on consistency in decision making, staff IT training, greater use of metrics for assessing performance and training, and standardizing process lifecycle management via quality components. The recommendations were stipulated under the 2012 Medical Device User Fee Amendments (MDUFA III).
Stage One of the CRDH plan entails near-term efforts including researching best practices, assessing existing department resources and capabilities, and conducting gap analyses to determine and prioritize process improvements. Business process maps are planned for 510(k) premarket notification and Premarket Approval (PMA) decisions as well as requests for Additional Information, PMA Major Deficiencies and Investigational Device Exemption (IDE) approval decisions.
Stage Two of the FDA’s action plan will include implementation of best practices across all areas identified in the Booz Allen Hamilton report. This longer-term phase of the FDA plan involves steps such as:
- Moving all device review processes under the CDRH Quality Management Framework
- Formalizing premarket IT training of all CDRH staff involved in submission reviews
- Developing a formal system to capture and monitor all quality issues
- Implementing formal document control processes
Stage One actions, meant to specifically address Booz Allen Hamilton recommendations, will be implemented by December 31, 2015, according to the FDA. No firm implementation date has been set for Stage Two actions.
What does the CRDH action plan mean for medical device companies registered (or registering) their products in the US via 510(k) or PMA applications? Hopefully the plan yields tangible and significant efficiencies for US medical device market authorization applicants; time will tell.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.