The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as of late October and will emphasize health equity going forward, an emphasis that is accompanied by at least one program that is already in place.
Shuren announced in July 2024 that he would step down from his post of director of CDRH, a position he has held as an acting or confirmed director since 2009. Shuren’s time at CDRH commenced when Margaret Hamburg took over as the FDA
commissioner. Tarver also joined CDRH in 2009 and has served in several capacities in the meantime. She has served as the Deputy Director of the Office of Strategic Partnerships and Technology Innovation at CDRH and directed the center’s patient engagement efforts as well.
FDA commissioner Robert Califf announced the appointment Oct. 24, stating that Tarver has a “strong understanding of the medical product ecosystem.” Califf said Tarver understands the impact of digital health on healthcare, and emphasized her experience interacting with patients, caregivers and industry as among her chief qualifications.
Califf had stated in July that a nationwide search would commence for Shuren’s replacement even as Tarver was immediately installed as the acting center director. Shuren had taken the role of center director emeritus upon his resignation, a role he indicated would come to an end before the beginning of calendar year 2025. He has stepped down from that role as of the date of Tarver’s appointment as full center director.
The FDA is likely to have a new commissioner in 2025 as the Biden administration departs from the White House, leaving the next commissioner with a number of technological challenges. Artificial intelligence (AI) is one of the primary regulatory issues facing CDRH, a technological area which Shuren has argued calls for new statutory authorities from Congress. One of the more pressing issues in connection with AI is the rise of generative AI as a potential diagnostic tool. The agency has scheduled a Nov. 20-21, 2024, advisory hearing to review a number of regulatory questions connected to generative AI.
CDRH is also in litigation over its final rule for regulation of lab-developed tests. Both the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) filed suit, although those two suits have been consolidated after filing in the U.S. District Court for the Eastern District of Texas. The lawsuits assert that the agency lacks sufficient statutory authority to regulate LDTs and that the final rule violates the Administrative Procedures Act. Congress can still pass the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would nullify the FDA rule and the associated lawsuits.
Tarver has stated that the CDRH emphasis on health equity will be domestic and global in scope, with much of the domestic emphasis enabled by the CDRH Home as a Health Care Hub program. This program, announced in April 2024, envisions a technology-based enablement of the home as a virtual care site that will require a comprehensive evaluation of how technology can be adapted to the home environment. One of the key elements of this program is the integration of multiple devices into a system that compensates for the fact that most devices for use in the home are not designed to interact with other devices in that setting. The prototype will be completed by the end of the year, the FDA stated.
The Advanced Medical Technology Association (AdvaMed) applauded the appointment of Tarver to the CDRH director’s office in an Oct. 22 announcement. AdvaMed CEO Scott Whitaker stated that AdvaMed is confident that Tarver understands the medical technology ecosystem and that she will employ a collaborative approach to managing CDRH. AdvaMed board chairman Peter Arduini stated that the FDA “has an especially difficult task ahead as AI plays an increasingly critical role in health care.” Arduini stated also that AdvaMed and industry “stand ready to work with FDA to ensure safe and effective lifesaving technologies are brought to market.”
Copyright © 2024 - Medmarc