Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA).
In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees needed to maintain staffing and other activities supported by the current level of user fees.
Also during that meeting, FDA presented an integrated proposal combining elements of industry’s and FDA’s proposals, which industry agreed to consider and to develop a counter proposal to present at the next meeting.
FDA proposed the addition of 20 full-time employees (FTEs) (16 for the Office of Device Evaluation (ODE) and four for the Office of In Vitro Diagnostics and Radiological Health (OIR)) to establish a quality management (QM) team, composed of a director and two branches, one of which would be responsible for QM and operations, including implementing a Corrective and Preventive Action (CAPA) system and development of knowledge management and document control procedures. The other branch would be responsible for measuring and monitoring quality through metrics development and analysis, as well as program audits and reporting.
FDA explained that lack of dedicated staff to conduct QM activities currently causes stress to the review system because staff time and attention are diverted from other activities that support the review process, according to the minutes from the meeting.
FDA also explained that the proposed structure is modeled after the quality management organization in the Patent and Trademark Office, which has a mature quality management system supporting a similar scientific and regulatory review program.
FDA further proposed shifting some compliance and surveillance activities into ODE to achieve a more integrated approach for the review of devices, which, if it were to be fully implemented by the end of MDUFA IV, FDA estimated 8 FTEs would be needed to establish the appropriate management structure and 6 FTEs would be needed as program operations staff.
FDA also proposed to hire 43 FTEs as device coordinators who would ensure consistency in process and feedback for each device’s entire regulatory lifespan, from pre-submission through marketing authorization, and to track the performance goals of the review pathways.
FDA called for the use of real-world evidence in premarket decision-making by building a system that links and improves the regulatory quality of data sources, such as data from electronic health records, healthcare claims and registries.
Industry, however, raised concerns about the use of claims data because off-label use or use by clinical staff without appropriate training for the device could yield data that would be difficult to use for the proposed purpose. But FDA said its plan would address those concerns and that the agency needs 15 FTEs and $10 million annually to address to tackle the issue.
FDA also included a plan to develop staff capacity to more efficiently and effectively review device submissions with Patient Preference Information (PPI) and to support the development and review of Patient Reported Outcomes (PROs), which it estimated would need the addition of 12 FTEs and $3.5 million over the course of five years.
For pre-submission meetings, FDA proposed that under MDUFA IV, industry would submit at least two proposed meeting dates in the pre-submission period; and within 15 days of receipt, FDA would accept one of the proposed dates or provide two alternative date options between day 30 and day 60; within seven days of FDA’s response, industry would accept one of the proposed dates or request additional options; within five days prior to the scheduled meeting (if the meeting occurs earlier than day 55), FDA would provide written feedback; and within 14 days of the meeting, FDA would provide meeting minutes.
Based on industry’s feedback, FDA modified their previous proposal to apply a “no submission left behind” mechanism if a meeting is not scheduled within 30 days. The agency also estimated that 57 FTEs would be needed to provide written feedback by day 55.
In terms of de novo submissions, FDA on 27 January presented an alternative proposal (after saying that achieving industry’s call for 90% performance in the first year of MDUFA IV is impractical) with “steadily improving performance targets that would achieve a decision on 80% of de novos within 120 days by the final year of MDUFA IV.” FDA estimated the cost of this proposal to be 61 FTEs and $200,000 annually in IT costs.
Third Party 510(k) Review
FDA presented details on ways to strengthen the third party premarket review program, with the suggestion of centrally tracking the scientific quality of the review through reviewer feedback tools, determining patterns in FDA deficiencies and letters with additional information requests and “Not-Substantially Equivalent” decisions, and developing audits for the application of cross-cutting and device-specific guidance documents.
FDA proposed steadily improving performance targets that would achieve decisions on 85% of third party 510(k)s within 30 days by the end of MDUFA IV, and estimated the cost of this proposal to be 17 FTEs and a total of $4.5 million in special operating costs.
FDA described its proposal for consistently reviewing software and issues related to digital health by increasing the number of experts available to support internal and external stakeholders.
“FDA noted that there have been inconsistencies in the identification of deficiencies in the review of software. FDA proposed a systematic, end-to-end evaluation and optimization of medical device software regulation,” the minutes said.
FDA noted that industry groups have expressed interest in a greater number of, and regular updates to, device-specific guidance documents and FDA proposed to establish a new model for streamlining such documents. FDA proposed to hire 12 FTEs who would be primarily technical writers to produce these device-specific guidance documents more efficiently.
On the recruitment and hiring front, FDA proposed the addition of six FTEs to further incorporate scientific and technical perspectives into its hiring process. FDA also proposed 20 FTEs to provide greater oversight of review procedures, to “oversee appropriateness and quality of deficiencies, and to allow branch chiefs the time for increased interactions with industry, such as through longer pre-submission meetings.” The agency also proposed performance-based incentives to improve management retention.
FDA briefly discussed the IT Modernization proposal that was detailed during the meeting on 15 December 2015, which includes development of the myDevices Portal and eSubmitter within a cloud-based portal that would enable electronic submissions, structured data and streamlined tracking.
The total cost of the integrated infrastructure proposal was estimated to be 46 FTEs, including targeted recruitment specialists, managers to enhance review oversight and consistency and the QM team.
FDA and industry also met 18 February, though the minutes from that meeting have not been released.
MDUFA III Performance
In addition to the meeting minutes on MDUFA IV, FDA also released on Friday a 374-page report on MDUFA III performance, which includes mostly charts and figures on CDRH’s work with PMAs, 510(k)s and IDEs.
FDA – Industry MDUFA IV Reauthorization Meeting 27 January
FDA – Industry MDUFA IV Reauthorization Meeting 20 January