The US Food and Drug Administration (FDA) has released the text of an outside assessment of how it reviews medical device submissions, saying it plans to quickly act on several "high priority" recommendations to improve its regulatory processes.
The medical device industry has often lambasted FDA's review process as being increasingly onerous, slow and unpredictable-a view also shared by government investigators. Though officials within the Center for Devices and Radiological Health (CDRH), and in particular Jeffery Shuren, have made efforts to improve the speed and reliability of the program, improvements are still seen by some as being needed.
That's where a new report is meant to make an impact. The report, conducted by Booz Allen Hamilton, was ordered under the terms of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which reauthorized the Medical Device User Fee Act (MDUFA). Section V of MDUFA, "Independent Assessment of Review Process Management," ordered a two-phase assessment of how FDA reviews device submissions.
The first of those phases focuses on what can be done in the near term, and includes an assessment of FDA's refuse to accept (RTA), substantive interaction (SI), interactive review (IR) and missed MDUFA decision (MDD) policies, as well as training, retention and IT infrastructure at FDA.
After extensively interviewing members of industry and FDA, looking at review data, consulting with stakeholders and assessing outside literature, Booz has come up with four main recommendations for FDA:
1.) Develop criteria and establish mechanisms to improve consistency in decision making throughout the review process
The report notes that a "recurring issue" identified during the research for the report was the inconsistent nature of FDA's review decisions, and in particular a "lack of transparency" that contributed to a feeling that CDRH regulated within a black box. In addition, reviewers frequently reference new standards that, while applicable to new submissions, were not necessarily in effect at the time of the original submission.
"Development of tools, criteria and/or mechanisms for assessing and ensuring the consistency of review processes would help ameliorate this issue," Booz wrote. Reviewers might also explain to companies early on in the process which standards they intend to use during review, the report speculated.
2.) Provide mandatory full staff training for the three primary IT systems that support MDUFA III reviews
FDA has made a number of IT upgrades in recent years which have contributed to some reviewers not knowing where to store documents, which documents to store and how to best integrate their work across systems. Not all reviewers have had training on the CDRH's Center Tracking System (CTS), its central document tracking tool for premarket submissions, Booz noted.
3.) Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes
FDA exists on the bleeding edge of scientific innovation, which can make it difficult for reviewers to understand the science behind the products they're reviewing-something made even more difficult by the challenge of keeping up-to-date with the latest scientific advancements and medical practices.
Even more difficult, reviewers need to know FDA's regulations inside and out. An inconsistent or incorrect application of review standards can slow down an application or, worse, improperly deny it, denying patients access to a safe and effective therapy.
Booz's report recommended focusing heavily on training and education for reviewers, including an assessment of the tools it uses to educate its staff and whether they are the best fit for purpose. Subsequent surveys and post-training courses could serve to make sure that things learned during the course are being retained by staff, Booz wrote.
4.) Adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews
In the longest section of the report, Booz made several major recommendations to improve the review process by making it more standardized.
For example, Booz recommended that the management of the review process be improved by formally documenting decisions to intervene in reviews and, if necessary, the decisions taken to bring a problem to resolution. This would further promote accountability, communication and proper follow-up, the report explained.
Further, staff should be oriented on how to best use CDRH's numerous document control databases. At present, staff were found to be using several quality control methods to keep track of documents, which made it difficult to track review statistics and find errors. Databases should be audited and a new standard implemented, Booz said.
Finally, Booz said CDRH needs to identify and develop internal metrics to continually assess how efficient and effective its review processes are. This would enable it to assess when metrics were not being met earlier on in the review process, allowing it to make process improvements in real time.
A more comprehensive assessment is set to be published in six months. FDA is also expected to unveil an implementation plan for the recommendations at that time.
Booz Allen Hamilton ReportFederal Register