Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a time when tech in healthcare is blowing up.
Her role involves regulating devices that now handle critical functions, like scanning for cancer, translating brain signals for those who’ve lost speech, and acting as hearing aids in the form of Apple AirPods. These devices have become essential to patient care, and the FDA’s oversight is under heavy scrutiny.
With the budget at $790 million and a staff of 2,500, this division’s task list is stacked. And with Tarver stepping in to replace Dr. Jeffrey Shuren, who pushed for faster device approvals and grew close to industry insiders, there’s even more pressure to act quickly but carefully.
In Shuren’s tenure, some of these close ties drew criticism, especially with his wife representing certain device makers, bringing ethical concerns. With Tarver now in charge, expectations are high.
She’s got to handle the massive influence of big tech in the medical device space and maintain standards that protect public health. Critics are watching, and Congress is paying attention. High-profile tech developments, like brain-computer interfaces, add even more complexity.
Brain-computer interfaces and Elon Musk’s influence
Brain-computer interfaces (BCIs) are one of the hottest and most challenging areas Tarver’s team will oversee. These devices decode brain signals and help people with paralysis regain movement, like playing Mario Kart or controlling a computer.
The FDA’s medical device division is responsible for approving trials and eventually deciding if these devices hit the market. Elon Musk’s company Neuralink, in particular, has been at the forefront of this field, developing implants that allow users to control digital devices with their thoughts.
Musk’s ambitions extend to devices he claims could restore sight to the blind. He is also loud about his frustrations with the FDA. In a recent campaign speech, he slammed the agency for not approving a cancer drug he said saved a friend’s mother, although that drug was actually cleared in 2021.
Musk has even argued that “overregulation kills people” and said that speeding up the FDA’s drug approvals “could save millions of lives.” Neuralink, which already got FDA clearance to implant its device in a second patient, is just one of Musk’s ventures likely to get extra attention, especially if the political tides shift in his favor.
Alongside him, Robert F. Kennedy Jr., another critic, has also rallied against the FDA’s industry ties and funding, noting that half the FDA’s budget comes from industry user fees. Both Musk and Kennedy’s public disapproval could spell trouble for the agency’s regulatory mission.
Two years from now, Tarver will have to negotiate new agreements on the FDA’s funding from industry fees, which account for nearly half of the $7.2 billion agency budget, including $362 million for the device division alone.
These talks will set the pace of device reviews and hiring, letting the FDA remain competitive in fields advancing at breakneck speeds. But the cozy financial relationship between the FDA and industry has always drawn scrutiny, with critics questioning if this arrangement compromises the agency’s independence.
Ethical dilemmas and Shuren’s legacy
Shuren’s time at the FDA left a mixed legacy. While he pushed for faster device approvals, his ethics were questioned, particularly over his involvement in negotiations where his wife’s law firm represented certain device companies.
In a recent investigation, The New York Times found Shuren overlooked ethics rules in cases involving his wife’s clients. Alcon, an eye-care giant and one of Shuren’s wife’s clients, was part of these negotiations, raising red flags for ethics experts.
According to federal ethics laws, officials shouldn’t handle matters where their spouse has a financial interest, and even though the FDA claimed Shuren avoided specific Alcon matters, many questioned if he maintained a fair distance.
Ethics experts emphasized that it’s not just about Shuren’s actions but about maintaining public trust in the FDA. The agreements Shuren negotiated include commitments like reviewing 95 percent of low-to-moderate-risk devices within 90 days.
Another significant decision was the Third Party Review program, where outside companies make initial approval decisions before the FDA gives the final nod. These policies have allowed device approvals to move faster, but the increased pace isn’t without risks.
AI in medical devices and FDA’s struggles to keep up
With AI tools now doing everything from spotting cancer in MRIs to assessing heart conditions, the FDA’s role is under pressure. Harvard researchers found that many cardiology devices approved as “moderate risk” had recalls later, revealing life-threatening issues.
In response to these recalls, Dr. Ezekiel Emanuel, a former federal health official, published an editorial calling for the FDA to prioritize safety over speed.
Doctors reviewing FDA-approved AI programs also found the agency’s records lacking. They want to know how these AI tools make decisions, but that transparency is often missing. Many AI programs, labeled as “low” or “moderate risk,” bypass the extensive testing required for high-risk devices.
A Stanford study recently found that 96 percent of nearly 700 AI tools cleared by the FDA didn’t include information on race or ethnicity. This omission raises concerns about bias and health disparities, especially if algorithms don’t consider diverse data in training.
A separate report from Mass General Brigham criticized the FDA for sparse performance data on certain programs. Despite these concerns, AI in healthcare is expanding fast, with potential in areas like drug development and fraud detection.
FDA Commissioner Robert Califf acknowledged these limitations in a recent conference, saying the agency would need triple the staff to monitor all AI programs effectively. He remarked that the current regulatory framework for devices is “50 years old” and not built to handle the speed and scale of AI in healthcare.
In a high-profile example, the FDA allowed Apple to market AirPods as hearing aids, blurring the lines between consumer electronics and medical devices. With more tech companies like Apple getting into healthcare, the pressure is on the FDA to set clear guidelines.
