MDUFA VI: Industry seeks changes to de novo, pre-submission programs

Medical device industry groups are proposing changes to the US Food and Drug Administration's (FDA) de novo and its pre-submission programs to improve their efficiency. Additionally, these groups are seeking more information about how the agency plans to use user fees to fund its real-world evidence (RWE) program. They are specifically requesting details regarding the full-time equivalents (FTEs) involved in this initiative.

These comments and recommendations were raised by industry during negotiations to renew the Medical Device User Fee Amendments (MDUFA VI) program for fiscal years 2028 to 2032. These proposals were mentioned in the meeting minutes from the MDUFA discussions held with industry representatives on 21 January. The current user fee program for devices will expire on 30 September 2027.

The meeting included representatives from the FDA’s Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), the FDA’s Office of the Chief Counsel (OCC), and consultants to FDA.

Representatives from the Advanced Medical Technology Association (AdvaMed), GE Healthcare, the Medical Device Manufacturers Association (MDMA), Medtronic, Boston Scientific, Siemens Healthineers, and Cook Medical were present from the industry.

At the meeting, FDA and industry presented proposals for the de novo and pre-submission programs and provided readouts from their working groups on areas of agreement and disagreement.

Industry identified three challenges facing the de novo program: One was the lower approval rate and withdrawals for de novo classification requests compared to other types of marketing submissions. The second complaint was the limited options for industry to respond to de novo decisions. Industry noted that the only way to respond to decisions is for sponsors to submit a new application or to file an appeal.

In addition, industry said there are limited options for devices that are ineligible for de novo classification, particularly for "second-place finishers." These are de novo submissions that were initially eligible and accepted for review but had not received a decision by the time another de novo submission that could serve as a predicate device was authorized.

The de novo classification program was established in 1997 as part of the Food and Drug Administration Modernization (FDAMA) to provide a pathway for novel, and low- to moderate-risk devices that do not have a legally marketed predicate device.

The minutes reflected that “progress was reported, with FDA and Industry reaching alignment on most proposals while identifying one area in a proposal requiring further deliberation—committing to regular discussion meetings during the review cycle. FDA and Industry agreed additional discussion is still needed and would be discussed in a future negotiation meeting.”

The industry also expressed its concerns regarding CDRH’s pre-submission program. These concerns include the strain on resources due to an increase in pre-submission requests, ineffective use of the pre-submission process, and inefficiencies in timelines. This includes the possibility of addressing certain pre-submissions before the established goal of 70 days.

FDA's CDRH established the pre-submission program in 1995 to provide feedback on investigational device exemption (IDE) applications. In 2012, the program was expanded to include all medical device premarket submissions and was renamed the Q-Submission program in 2014.

The two sides reached an agreement on faster feedback options and the bundling of traditional pre-submissions. The FDA and industry also agreed to a follow-up discussion on the pre-submission program on 11 February 2026.

Another topic of discussion was the FDA’s RWE program for medical devices. Industry representatives expressed strong support for the National Evaluation System for Health Technology (NEST), highlighting that the NEST Mark could be an “important future tool” for assessing the quality of RWE.

The NEST Mark program, managed by the Medical Device Innovation Consortium (MDIC), is an FDA-CDRH-supported initiative that streamlines regulatory submissions for medical devices. It promotes the use of real-world data to expedite premarket approvals and postmarket studies.

The industry requested more information about the FDA's proposed investment in RWE for the next iteration of MDUFA. Specifically, the industry asked for details on the full-time equivalents (FTEs) involved in RWE initiatives. They also wanted the FDA to clarify the data sources being used for RWE collection and to outline the current roles of the FTEs related to RWE. In response, the FDA stated that it would provide this information later.

FDA and industry agreed to leverage the language from the MDUFA V commitment letter when drafting the MDUFA VI commitment for funding NEST.

The FDA and industry also reached an agreement on a set of goals for the total time to decision (TTD) for 510(k)s. These goals will use the same calculation methodology as previous MDUFA cycles. The TTD goal will decrease from 128 days in fiscal year 2028 to 112 days by fiscal year 2032.

Minutes

MDUFA VI: Industry seeks changes to de novo, pre-submission programs

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