Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.
In FY2018, which began in October 2017, the fee for de novo submission increases to over $23,000 for a small business and over $93,000 for large companies. This increase will radically impact regulatory budgets for small companies with innovative products, but the additional fee will (hopefully) come with benefits of decreasing review times. With the additional fee, FDA will be able to dedicate resources to the de novo program, specially trained in how the de novo differs from reviewing a 510(k) or PMA and the ability to efficiently draft classification regulation when the review is complete.
The discouraging increase in the de novo fee will encourage more creativity in the use of the 510(k) pathway. The 510(k) pathway will be far and away the least expensive and quickest path to market if a substantial equivalent argument is even remotely possible. In the last years, FDA has issued guidances on how to best leverage a predicate with reference devices to support new indications, evaluating new or different technological characteristics, and crafting a benefit-risk argument for new technology. Industry must perform an in depth analysis of intended use, indications, technology, and all possible comparative devices or technology to understand the most viable path. If the 510(k) is successful, the product receives classification as a class II device and the company saves time and money. Even if a 510(k) for a novel device results in a non-substantial equivalence determination, the company receives a detailed, documented, binding, and actionable list of concerns that can be used to convert the submission to a successful de novo. While the pre-submission meeting process can be valuable to glean some of this information from FDA, the outcomes are non-binding and at times involve a bit of speculation as to what the FDA will actually accept or that their opinion will be consistent when the submission is ready. For considerations to your submission strategy see FDA guidances The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, and Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.
Companies should also remember that small business determinations must be obtained from the FDA on an annual basis. If your company plans to submit any type of submission in FY2018, be sure to apply according to the guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification.
With nearly 20 years of healthcare product experience, Michelle Lott has distinguished herself in the industry with uniquely simple solutions to complex regulatory challenges. Michelle’s depth and scope of experience enable her to drive regulatory and business success. Michelle’s specialties include crafting successful regulatory submissions and quality management systems for startup companies. For large companies, Michelle offers remediation services and quality culture reprogramming. She founded Lean RAQA Systems, LLC, a Regulatory and Quality system solutions company, with the mission to Make Quality Make Sense™. She has also previously held executive leadership roles for international regulatory and quality operations. Michelle is currently serving on the FDA’s Device Good Manufacturing Practices (DGMP) Advisory Committee as an industry representative, providing strategy and guidance to FDA on key topics. She continues to run her own company, providing thought -leadership through her blog & newsletter.