US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says.
The medical device industry has often lambasted the US Food and Drug Administration'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.
In 2012, legislators committed to moving the dialogue about CDRH's apparent problems forward by commissioning a new report, an "Independent Assessment of Review Process Management" focused on how CDRH reviews device submissions.
The first phase of the draft report, authored by the consulting group Booz Allen Hamilton and released in December 2013, 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.
The draft report called for four major changes along the lines of what Booz Allen called "priority recommendations."
- develop criteria and establish mechanisms to improve consistency in decision making throughout the review process
- provide mandatory full staff training for the three primary IT systems that support MDUFA III reviews
- identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes
- adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews
Now FDA has released the text of Booz Allen's final report, a 147-page behemoth, as well as a much shorter "plan of action" detailing what FDA plans to do to improve.
Booz Allen's report serves as a comprehensive look at what's wrong at CDRH, as well as how it might be fixed—more than Focus can possibly summarize in this article.
But perhaps more interesting than the report is CDRH's response to it indicating what steps it will be taking to address the report's concerns.
For example, CDRH says it will immediately begin to "inventory and, as needed, develop business process maps for 510(k) clearance decisions, premarket application (PMA) approval decisions, 510(k) requests for Additional Information (AI), PMA Major Deficiencies, and Investigational Device Exemption (IDE) approval decisions." The agency will then conduct a gap analysis to identify where its processes and procedures can be improved, it said.
After that, FDA said it will look to identify best practices and lessons for training its employees on its IT systems to better support MDUFA III reviews, and develop mechanisms to share knowledge and measure decision-making consistency.
Training staff forms a huge component of FDA's plan—and Booz Allen's report—and FDA said it is committed to identifying shortcomings in its staff training, including their training on its technology platforms like DocMan and Image2000+.
A key part of that training plan will involve FDA researching best practices for evaluating training success within other organizations, like the US Patent and Trademark Office (US PTO). Eventually, the training evaluation plan developed by CDRH will apply to all premarket review training, it said.
As further explained by FDA in its Federal Register notice on the report:
"FDA will incorporate findings and recommendations, as appropriate, into its management of the premarket review program. FDA will analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and assure its effectiveness. FDA also will incorporate the results of the assessment into a Good Review Management Practices (GRMP) guidance document for medical devices. FDA's implementation of the GRMP guidance will include initial and ongoing training of FDA staff, and periodic audits of compliance with the guidance."
The second phase of the report is set to be published no later than 1 February 2016, FDA said.
MDUFA Report Page