Vision check with FDA CDRH Director Dr. Michelle Tarver

Dr. Michelle Tarver, FDA CDRH director and former ophthalmologist, spoke at AdvaMed’s Medtech Conference in October. [Photo courtesy of AdvaMed]

Dr. Michelle Tarver, a veteran leader at the FDA, is director of the Center for Devices and Radiological Health at a pivotal time in medtech.

Tarver has spent over 15 years as a medical device regulator within the FDA and has extensive policy experience in regulation, crafting guidance and conducting premarket and postmarket reviews. Her appointment comes as emerging technologies like artificial intelligence and the growing demand for equitable healthcare solutions challenge medtech companies and regulators.

“It’s definitely an honor to be able to serve with so many people who are so connected to the mission of ensuring that the U.S. public has access to safe and effective medical devices,” Tarver said in an interview with Medical Design & Outsourcing.

Tarver said she’ll balance device innovation, safety, equity, and usability. Her vision for CDRH includes supporting device developers with tailored resources, collaboration, and addressing regulatory challenges that arise with emerging technologies.

“It’s an exciting time for medical devices, where we’re increasingly seeing new technology like artificial intelligence and machine learning, as well as new diagnostic approaches [and] new therapeutic options coming onto the market, and patients also being able to utilize more of those technologies within the walls of their own home. It really has fostered greater empowerment by patients to be true agents in their own healthcare solutions,” Tarver said.

More collaboration and FDA resources for developers

Dr. Michelle Tarver replaced Jeff Shuren as acting director of the FDA’s Center for Devices and Radiological Health (CDRH) in July 2024 and was named permanent director in October. [Photo courtesy of the FDA]

One of Tarver’s main goals is to improve collaboration between the FDA and device developers. Programs like the FDA’s collaborative communities initiative allow manufacturers, regulators, and patient advocates to address shared challenges.

The FDA also plans to expand other resources built for device developers, like the Total Product Life Cycle Advisory Program (TAP), which supports companies in developing and approving breakthrough devices. The program accelerates the development and market access of innovative devices that are deemed critical to public health. It was initially launched as part of the FDA’s MDUFA V commitments and focuses on fostering early, frequent, and strategic communication between medical device companies and the FDA.

“This program is specifically geared for those devices that meet the breakthrough designation criteria,” Tarver said. “And they will get a TAP advisor that helps connect them to the different offices … giving them helpful insights as they navigate the process.”

Tarver also emphasized that engaging with the FDA early in the development process can help companies avoid setbacks and accelerate the time it takes to get to market.

The role of digital health

Digital health technology gives opportunities for improved healthcare access and outcomes. Tarver highlighted the importance of designing technologies that empower patients and integrate seamlessly into their lives.

“If we understand the lived environment for people who have the least amount of resources, we can understand better how those devices may need to nestle into those homes in a way that is going to promote people wanting to engage with those devices as well as nestle seamlessly in the background, so they don’t overtake the home,” Tarver said. “Home is where we like to be with our family and our friends and where we relax. We don’t want to transform homes into little clinics. And so, how do we imagine an environment that allows the smallest footprint to experience the biggest benefit from those devices moving into the home?”

By leveraging virtual reality-enabled prototypes, the FDA is working with device developers to simulate how their products might fit into a variety of living spaces for effectiveness with minimal disruption to patients’ daily lives.

Balancing innovation and oversight

Tarver has a unique perspective on the needs of medical device developers.

“Having had a foot both in the postmarket and the premarket arena at various points of my career, I have an appreciation for the importance of both,” Tarver said. “Both the innovation that fuels and catalyzes a lot of the premarket submissions that we see come through our doors, as well as the importance of having responsible oversight of those devices when they’re in the U.S. marketplace to ensure they continue to perform as expected and they remain safe and effective.”

For device makers, this means keeping up with evolving regulatory expectations, particularly for emerging technologies like AI.

AI and machine learning are powering new diagnostics, treatments, and patient monitoring systems.

“Artificial intelligence is an algorithm that is trained on a particular data set and validated in a certain context,” she said. “But when it’s in real-world use, there can be challenges. And so I think at each point along that node, meaning the data that’s used to train the algorithm, does it reflect the intended use population, and is it appropriately vetted to ensure that it performs as expected?”

Focusing on diversity in clinical trials

Tarver has been an advocate for diversity in clinical trials, emphasizing the importance of designing device studies that reflect their intended populations.

The FDA’s diversity action plans encourage manufacturers to include underrepresented groups, such as racial and ethnic minorities, women, and older adults, in their trials.

FDA CDRH Director Dr. Michelle Tarver [Photo courtesy of FDA]

“In 2022 through 2025, we put forward a strategic priority that no person should be left behind in healthcare,” Tarver said, “and that we were going to take deliberate actions to help advance health equity for those who live in various geographic locations, across the age spectrum, people of different sex, people with different racial and ethnic groups, [and] physical limitations.”

Digital health technologies can help overcome barriers to participation, such as geographic distance and various caregiver responsibilities. Remote data collection and virtual trial designs are also emerging as tools to increase trial inclusivity.

In addition to support for digital solutions, the FDA’s diversity action plans encourage manufacturers to actively engage with communities historically excluded from clinical trials. This includes partnering with local organizations to build trust and developing logistical support to enable participation.

“Ensuring that the evidence generated in a clinical trial reflects the people who will use the device… is how we can foster trust and improve health outcomes for everyone,” Tarver said.

Transparency measures such as the FDA’s device snapshot program, which publicly displays demographic data from clinical trials, help patients and providers better understand who was represented in studies supporting device approvals.

Tarver has been “instrumental” in getting the FDA to make age, sex and demographic data available for adverse events, said DeviceEvents founder and CEO Madris Kinard, who is also a patient advocate for better transparency between the FDA and patients.

“There has been progress in which the FDA is recommending that clinical trials be expanded to women and minorities. It will be difficult to know for a while if that is successful. Many devices are also used primarily in the medicare population (typically 65+), but the devices were tested in younger individuals,” said

Driving quality and reliability in manufacturing

Tarver’s leadership builds on FDA initiatives to support device developers like the Case for Quality program, which encourages manufacturers to implement quality-focused processes beyond basic compliance.to improve device reliability, reduce risk and expedite patient access.

“We’ve matured that program, looking at ways in which we can encourage companies to inculcate quality across their entire organization,” Tarver said.

The program also recognizes and shares successful manufacturing practices that can serve as benchmarks for the device industry, including third-party assessments through initiatives like the Voluntary Improvement Program, which helps manufacturers identify areas for improvement while reducing regulatory burdens.

“Companies who invest in quality not only improve their manufacturing outcomes but also experience fewer product complaints and higher customer satisfaction,” Tarver said.

Additionally, the FDA continues to refine its postmarket surveillance strategies to ensure devices remain safe and effective once they enter the market. Efforts to enhance transparency in recalls, improve manufacturing quality, and streamline regulatory processes are a part of these initiatives.

“It’s about fostering a culture of continuous improvement,” Tarver said. “When manufacturers prioritize quality, it benefits everyone – from the developers and regulators to the providers and patients who rely on these devices every day.”