MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations

Regulatory NewsRegulatory News | 20 April 2021 |  By 

After a delayed start, the US Food and Drug Administration (FDA) released minutes from the first two meetings held with the medical device industry to negotiation the terms of the next Medical Device User Fee Amendments (MDUFA V) program.
FDA and industry had originally planned to kick off the MDUFA V negotiations with a public meeting last April, but the meeting was delayed by six months due to COVID-19. (RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020).
In the first meeting, held virtually on 24 February, FDA officials called the MDUFA IV program a success while industry groups, including the Advanced Medical Technology Association (AdvaMed), Medical Imaging and Technology Alliance (MITA), Medical Device Manufacturers Association (MDMA) and American Clinical Laboratory Association (ACLA) sought refinements to the program while setting limits on its funding.
FDA pointed out that it met all its MDUFA IV review performance goals in FY2018 and has met the same goals for FY2019 and FY2020 for sufficiently complete cohorts where an outcome could be determined.
Despite hitting its shared goal with industry on total time to decision (TTD) for premarket approvals and 510(k)s in FY2018, FDA says that TTD performance for 510(k) has plateaued since FY2013 and suggests making changes in MDUFA V that could reduce the number of review cycles through improved submission quality.
FDA said it has met most of its performance enhancement commitments for FY2018-2020, including those related to quality management, guidances, real-world evidence, patient engagement, time-reporting and total product life cycle (TPLC) reorganization. The agency also cites the MDUFA IV Phase I Independent Assessment, which credited the agency with “standardizing CDRH operations, increasing staff knowledge to perform submission reviews, increasing regulatory process clarity, and improving decision-making consistency.”
Outside MDUFA-specific activities, FDA touted its efforts to advance patient engagement and the use of real-world evidence in regulatory decision-making, as well as hitting new highs for breakthrough device designations in 2020 and novel device authorizations in 2018 and 2020.
“With the additional resources and commitments under MDUFA IV, FDA has continued to build a program that delivers—and continues to improve—consistency, predictability, and transparency in service of timely patient access to high-quality, safe and effective medical devices,” the agency said.
However, FDA said it is “seeing signs of strain” more than a year into its response to the COVID-19 pandemic and expects MDUFA performance to be impacted in FY2021 and beyond.
While affirming their support for the MDUFA program, the industry groups stressed their view that user fee funding should only be used to pay for the premarket review process and that congressional appropriations should remain the primary source of CDRH and the Center for Biologics Evaluation and Research (CBER) funding.
Instead of expanding the program, industry said its goals for MDUFA V are to “focus on fundamentals” and to establish an accurate baseline for the program.
Industry took aim at FDA’s staffing performance under MDUFA IV, citing 36 vacant MDUFA IV full-time equivalent (FTE) positions and that the number of FTEs involved in device reviews decreased from FY2018 to FY2019.
The device groups also said they hope FDA will be able to clear any COVID-related submissions backlog by the end of the MDUFA IV program and expressed interest in incorporating lessons learned from the pandemic into MDUFA V.
As for establishing a baseline, industry said it wants to get a better view of how FDA calculates MDUFA costs per FTE and how the agency will use the carryover balance it has accrued to support the premarket review process. Industry also dismissed the notion of carrying forward any one-time costs from MDUFA IV into the baseline for MDUFA V.
In their second meeting, FDA and industry focused on reviewing external stakeholder feedback on MDUFA reauthorizations, performance, financials and digital transformation, as well as FDA’s methodology for calculating FTEs and its recruitment and retention efforts related to MDUFA IV positions.
FDA also took issue with industry’s characterization from the previous meeting that its MDUFA IV performance was “not being met or unlikely to be met.” On the TTD goal, FDA reminded industry that this is a shared outcome goal and asked that industry provide information at the following meeting on 7 April on its actions to advance the goal during MDUFA IV.
The two sides also clashed over whether FDA met its MDUFA IV commitments related to digital health and deficiency letters. FDA said it met its commitments on deficiency letters by publishing an updated guidance, providing training for its staff and managers and by completing an audit by FY2020.
Industry disagreed, with the two sides taking different views of the MDUFA IV commitment letter: “Industry interpreted the commitment letter as reflecting a commitment that all deficiency letters would include a statement for the basis of the deficiency, and stated that FDA had missed this goal. FDA explained that it does not view the deficiency letter provision as a commitment to 100%, but rather, an aspirational goal of 100%, towards which it is diligently working and expecting to see improvements.”
FDA also said it would need more resources to make this an actionable goal of 100% compliance.
Industry, on the other hand, pointed to CDRH’s own quality management audit that found the agency only provided a basis for deficiencies 25% of the time in FY2019 and 50% of the time in FY2020, though FDA said the audit “reflected a higher standard than the commitment letter.”
While industry maintained that it is critical for FDA to provide justification for deficiencies so that it can understand regulatory requirements and address them, FDA suggested that focusing on citations in deficiency letters “could be distracting from a possible mutual goal of promoting high-quality premarket submissions that do not necessitate the need for any deficiency letters to be issued.”
The two sides’ disagreements continued over to funding. FDA, seeking additional resources to expand the MDUFA program, pointed out that it collects nearly eight times as much fee revenue across its human drugs programs as it does under MDUFA. The device groups balked at the comparison, noting differences between the drug and device industries and market and suggesting that increasing fee revenue could increase the perception of regulatory capture.
How FDA plans to use the MDUFA IV carryover balance, which has grown to more than $200 million in available and $89 million in unavailable funds, was also a subject of contention: “Although FDA indicated that it had previously discussed this with industry members and how the funds were obtained to support implementation of the Digital Transformation Initiative, industry participants at the meeting indicated that they had not been previously informed regarding FDA’s view of how funds from the carryover balance should be used.”
Industry in turn raised concerns about the “existence of significant carryover balances at a time when MDUFA submissions are being delayed due to FDA’s focus on responding to the COVID-19 pandemic” and asked FDA whether the balances accumulated due to lack of hiring. The device groups instead called for carryover funds to be used to enhance premarket activities.
FDA’s methodology for calculating fully loaded FTE costs was also discussed and could be a potential target for revision in MDUFA V, with industry asking for additional details on factors that would affect the average cost per FTE methodology. FDA said it would be open to looking at whether non-pay costs could be isolated to CDRH, CBER, the Office of Regulatory Affairs and agency headquarters.
FDA also defended its hiring and retention efforts and said that despite challenges in FY2018 and FY2019, it was able to fill 92% of new MDUFA IV positions through the end of FY2020 and expects to meet its hiring targets this year.
Minutes: 24 February Meeting, 17 March Meeting


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