New CDRH Leadership Ensures Innovation and Safety Remain Top Priorities
In one of her first keynote addresses and follow-up interviews since her appointment as the permanent Director of the Center for Devices and Radiological Health (CDRH), Dr. Michelle Tarver emphasized: “…innovation and safety have been and will continue to serve as foundational pillars of CDRH.”
With less than three weeks in her role, Dr. Tarver demonstrated exceptional leadership, generosity, and authenticity at MassMedic Regulatory Roundup, leaving the audience both well-informed and with a profound appreciation for her perspective and expertise.
Here are five key takeaways from the event:
Amra Racic, VP Government Strategy, Veeva MedTech, interviews CDRH Director Dr. Michelle Tarver
1. There is an unwavering focus on patient safety
While there may be some uncertainty surrounding how the FDA will evolve to meet future changes, one thing remains clear: the CDRH is steadfast in its commitment to patient safety. Innovation and safety continue to be the agency’s core pillars and will remain its guiding constants. CDRH’s mission is firmly rooted in ensuring that U.S. patients have access to high-quality, safe, and effective medical devices.
2. MDUFA V performance metrics are on track for 2024
The FDA is performing exceptionally well in fulfilling the commitments established during the most recent MDUFA V negotiations with industry, consistently meeting and often surpassing key metrics. Dr. Tarver shared that the agency is seeing a sustained increase in novel device authorizations, while the Breakthrough Devices Program also continues to expand significantly.
3. The Office of Regulatory Affairs is now the Office of Inspections and Investigations
As anticipated, the FDA reorganized the Office of Regulatory Affairs on October 1, establishing the new Office of Inspections and Investigations as an extension across the agency. This restructuring aims to enhance FDA oversight of all regulated products, fostering stronger collaboration across field investigations throughout the agency. The reorganization is designed to modernize and fortify the FDA, enabling it to work more cohesively and collaboratively in advancing its public health mission.
4. New initiatives will improve operational efficiencies within CDRH
Dr. Tarver highlighted two key initiatives aimed at enhancing operational efficiencies for her team of nearly 2,500 staff members:
TAP (Total Product Lifecycle Program): Designed to accelerate the development of high-quality, safe, effective, and innovative medical devices essential to public health, the TAP initiative will help alleviate the burden on manufacturers while enabling the FDA to streamline its own review processes. TAP aims to reduce redundancies and optimize evidence generation, benefiting both industry and agency operations.
eSTAR: The eSTAR initiative, an interactive electronic submission PDF template, has significantly improved the medical device ecosystem by simplifying submission processes for manufacturers. While the tool offers many advantages to those submitting 510(k) and De Novos, the FDA recognizes it has room for improvement, especially as it considers expanding eSTAR’s use for larger submissions, such as PMAs. Dr. Tarver noted that staff have encountered challenges, including limited functionality for uploading graphics, which has led to plans for future upgrades. The FDA continues to encourage industry feedback as it enhances the eSTAR platform.
5. Health equity will likely remain beyond the 2025 strategic plan
Dr. Tarver consistently showcases her commitment to advancing health equity initiatives, striving to ensure all populations have equitable access to medical technologies that work for them, regardless of race, sex, geographic location, or other factors. While the current strategic priority on health equity is set to conclude at the end of 2025, Dr. Tarver shared that elements of this mission will likely carry forward into the next strategic plan. Future focus areas may include leveraging the home as a health care hub and addressing accessibility of digital health technologies for patients in remote locations, with lower literacy levels and fewer resources. She emphasized that “technology serves as a vital connector” in this effort, bridging gaps between underserved rural populations and healthcare opportunities.
To learn more about how industry leaders are prioritizing health equity to improve patient experiences, read this article.
