By
Allyson B. Mullen –
By In early February, Booz Allen Hamilton (“Booz Allen”) issued its
Final Implementation Report assessing the actions taken by CDRH to address the firm’s earlier recommendations to improve the Center’s premarket review activities. We previously blogged on Booz Allen’s recommendations and CDRH’s plan of action
here and
here.
Booz Allen’s report summarizes a number of key projects completed by the Center in an effort to promote predictable, efficient, and consistent premarket reviews. These projects address all 11 of Booz Allen’s recommendations from its earlier reports. A few of the most notable actions taken by CDRH are:
- Identification of short- and long-term review process to track and monitor for quality. These metrics include Refuse to Accept (RTA) decisions and final decisions.
- Rolling out the SMART template, “a self-guided tool for reviewers based on standardized operating procedures to handle similar issues encountered on different submissions.”
- Revised the 510(k) RTA guidance and checklist. We saw several improvements in the revised guidance, which we blogged on here.
- Implementing internal work instructions for withdrawal decisions and interactive review communications with sponsors.
- Revised the eCopy guidance to emphasize the importance of the use of features that facilitate searching and navigation.
While FDA has completed all of the above projects, there was insufficient time for Booz Allen to assess the implementation and effectiveness for the majority of these projects. Therefore, the report was unable to do more than speculate as to whether these actions will ultimately address the underlying concerns that prompted Booz Allen’s original review and whether additional actions may be necessary.
It is also too soon to know if these efforts will translate into shorter or more predictable review times for industry. In the report’s discussion of CDRH’s actions leading to the steps above, there are a few interesting points/statistics:
- Based on a review of 510(k) submissions from calendar year 2013, it was found that 510(k)s that were refused during the RTA process were associated with overall longer review times.
- An audit of 731 submissions, received over a three month period, showed that:
- on average sponsors missed eight (8) criteria in the checklist, with more than 75% of submissions missing more than 4 criteria,
- 66% of submissions did not include an RTA checklist completed by the sponsor instructing FDA as to where and how each element was addressed in the submission,
- The top four (4) most frequently missed criteria were: (i) shelf life methods (element 28); (ii) prior submissions (element 9); (iii) substantial equivalence rationale (element 16); and (iv) performance data – full test reports provided (element 36),
- Substantive review occurred in only a small number of RTA reviews (11%) and substantive review was not generally the sole cause for a refusal, and
- When substantive review did occur, it most frequently occurred in the reviewer’s assessment of the device description.
- ODE reviewers were trained not to interact with submitters during the RTA review process whereas OIR reviewers worked interactively with submitters during RTA review. The report states that “CDRH subsequently concluded that [interactive review] during RTA may reduce the rate of RTA elements requiring clarification.” It appears this conclusion was reflected in the revised RTA process. We hope that based on the revised guidance, ODE reviews will follow the lead of OIR reviewers with regard to RTA reviews.
- A survey of CDRH review staff regarding eCopy issues identified that:
- Nearly 80% of reviewers were reviewing non-searchable eCopy submissions, which led to an increase in review time, and
- Almost 90% of reviewers reported reviewing submissions that did not include bookmarks or hyperlinks, and this could add to the review time.
Sponsors taking note of some of these points could improve their odds of a successful premarket review. Providing a completed RTA checklist and a searchable eCopy are two small steps that industry could take on its end to facilitate smoother 510(k) reviews
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