CDRH's Dr. Shuren Discusses Support for Market Entry

Dr. Jeffrey Shuren, Director of the US FDA's Center for Devices and Radiological Health (CDRH), stepped to the podium on May 15, 2024, at the Food and Drug Law Institute (FDLI) Annual Conference. Dr. Shuren provided an update on CDRH program initiatives and discussed the Center's future.

The strategic priorities of CDRH 2022-2025 include promoting a modern and diverse workforce, enhancing organizational agility and resilience, and advancing health equity. Dr. Shuren supported the strategic priorities by outlining that by December 31, 2025, more than 50 percent of manufacturers of newly authorized novel technologies for the US market will have brought their technology to the US first or in parallel with other major markets. This evidence was presented without challenge and does not account for European Union (EU) market players struggling to meet Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements in part due to a lack of qualified Notified Bodies. EU market players have, in some instances, sought product launches in the US first while riding out the delays in MDR/IVDR implementation. Dr. Shuren reported that in 2023, there were 124 novel device authorizations, the most since 2010, exclusive of Emergency Use Authorizations.

Dr. Shuren highlighted the Breakthrough Technologies and the Safer Technologies Program (STeP). The breakthrough technologies program focuses on innovations that will significantly improve the outcomes of patients with life-threatening conditions. At the same time, the STeP program focuses on new technologies that significantly improve outcomes over the technology currently on the market, exclusive of life-threatening conditions and inclusive of conditions that may be fully reversible. There have been 975 devices that received breakthrough designation since 2015, resulting in 114 marketing authorizations. The STeP program launched in March 2021. Since then, there have been more than 100 requests for entrance, 42 granted, and two marketing authorizations. Dr. Shuren stated that CDRH will seek to understand why both programs' success rates are low.

MDUFA V focused on shortening the approval time for new devices. The focus has expanded to drive innovation and ensure the safe and effective development of those new devices. The primary goal is to reduce the number of deficiency letters issued and to drive first-cycle review success. The pre-market program is under review to better understand how to reach the first-cycle success goals.

In striving for first-cycle approval, the FDA is putting resources into proactively sharing information and resources to support emerging technologies. Dr. Shuren pointed to the whitepaper, "Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," and the publishing of the final guidance document on predetermined change control plans for AI-enabled devices. Additionally, there has been draft guidance for AI/ML content and lifecycle management, as well as education on the use of AI in clinical decision-making. 900 AI-enabled medical devices have been submitted for review.

Additionally, CDRH is working to support the use of real-world evidence by publishing draft guidance on the subject. Further, a collaboration of regulators, patient groups, industry, payers, health care systems, and clinician groups operating as NEST, the National Evaluation System for Health Technology, is working to create independent repositories of data that sponsors can use to derive real-world evidence in support of new technology submissions. NEST is an opportunity for developers to use independent data sources instead of sponsor-owned registries for evidence to support safety and effectiveness.

Finally, the Total Product Lifecycle Advisory Program, TAP, was discussed. The TAP program is a voluntary program intended to provide early, frequent, and strategic communications between the FDA and the sponsor to bring new technologies to patients as early as possible. Dr. Shuren described the program as the FDA's proactive reaction to innovation and change, without solicitation in some cases. He explained this as the FDA working with the sponsor to prompt them to consider potential pitfalls that may delay their success in the market. Additionally, the TAP program engages payers, providers, and patients early to ensure all stakeholders are considered early in the development process, further leading to market success. To date, 45 devices have been enrolled in TAP. The program began with cardiology devices and has now expanded to neurology devices. TAP established 14, 21, and 40-day responses on inquiries to the FDA to expedite the information exchange process with formal feedback from the FDA that the sponsor can rely on in the development and submission process.

It is not uncommon for clients to claim that they are not getting communications from the FDA on relevant questions they pose regarding their technology. As Dr. Shuren describes, CDRH is focused on collaborative processes to help bring innovation to patients in need. Perhaps one of the programs highlighted by Dr. Shuren is an opportunity to formally enter into talks with CDRH to promote your market presence and success.