FDA regulation of AI: challenging before, now what?
Volume 11, Issue 8 | February 20, 2025
ALSO IN THIS ISSUE
Administration cuts medical device staff at FDA, Lab Leadership at CDC / CDRH
Bird Flu: Administration “accidentally” fires critical staff
Bird Flu: Clothes-to-cat transmission?
Blood test for early stroke diagnosis
Employee cuts hit FDA medical device / Dx area, CDC’s Laboratory Leadership Service
Among the cuts the administration made to US government agencies in the name of efficiency this past week were the FDA’s head of medical device safety, safety reviewers of AI-enabled medical devices (see article below), and workers hired to improve the review process for medical devices, according to STAT News. At least 16 of the 24 fellows in the CDC’s Laboratory Leadership Service were also let go, the Associated Press reported. They described that service as a “leadership program [that] brought in doctorate-holding professionals who could help the CDC and state health labs improve testing while complying with demanding federal standards. It also was designed to be a way to recruit top talent to the CDC.”
The Advanced Medical Technology Association (AdvaMed) responded to the cuts in the medical device area with an open letter to the administration. It reads, in part:
“Without the essential expertise and capacity at FDA required to conduct pre-market reviews, clearances, approvals, and post-approval safety monitoring of critical innovative medical technologies and devices, not only are American patients at risk—our nation’s position as the number-one country for medical device innovation is as well.”
COMMENTARY: As Dr. Katelyn Jetelina stated when describing the administration’s cuts to public-health staff, this is not the way you achieve efficiency in government. “This is a blunt-force budget cut with no clear strategy—gutting programs without considering their impact or even how services could be improved for the American people,” she wrote. We agree.
Bird Flu Update: Administration “accidentally” fires critical staff
Administration firing probationary staff wholesale
According to NBC News, the administration says it has “accidentally” fired staff critical to the nation’s response to the bird flu outbreak.
The executive branch has been firing broad swaths of federal government employees whose status is “probationary,” because employees with that status have fewer legal rights when they are let go. (In some cases, probationary employees are people who have been hired within the past year or so - often highly skilled workers. In other cases, they are employees who have been promoted from within and may have years or decades of civil-service experience.)
But because the administration is not checking what these probationary employees actually do, it has been terminating people whose jobs are critical to their agency’s function. (In addition to USDA, affected agencies include the National Park Service and the National Nuclear Security Administration, among others.)
Although USDA officials told NBC that they are working to rehire the employees in question, in similar cases government officials have had difficulty contacting fired employees, as their email accounts have been terminated.
Asymptomatic cattle infected with wild bird strain can shed virus into milk
Milk from cattle in Arizona who had no bird-flu symptoms has tested positive for the virus. The herd has the D1.1 strain of the virus, which is usually carried by wild birds. A herd in Nevada that was infected with the same strain also did not show symptoms until after the virus was detected in its milk.
Delayed CDC bird-flu studies slowly being released
CDC studies on bird flu are slowly being published after having been delayed for weeks. One study, on asymptomatic infections in people, was published in the Morbidity and Mortality Weekly Report last week. Another finally appeared this week. As KFF Health News reported, it “describes how a milk hauler and a dairy worker in Michigan may have spread bird flu to their pet cats,” all of whom died. It looks like they brought the flu home on their clothes. (As we reported last week, the mortality rate for cats from bird flu is currently estimated at 67%.) A third article remains unpublished. According to KFF Health News, it “refers to ‘the most comprehensive’ analysis of bird flu virus detected in wastewater in the United States.”
FDA’s regulation of AI was challenging. Now it’s disastrous.
Regulating AI in medical devices is a tricky business. Ideally, such regulation must safeguard patients from medical error while still permitting rapid innovation - but how?
A summary of the FDA’s approach to AI regulation appeared in JAMA last month (i.e., before the current administration came into power). At that time, FDA regulations were based on the level of risk to patients. AI in devices performing only administrative functions would be unregulated, while AI inside diagnostic devices would require prior approval. AI providing clinical decision support - a bit of a gray zone - would be evaluated case by case. If the model in question was substituting for physician decision-making, it would be regulated. If it was just supporting decision-making, the AI would be left unregulated. (This, by the way, is by no means a clear dividing line, as a recent JAMA perspective by former FDA Commissioner Scott Gottlieb explains.)
FDA also acknowledged that AI presents two regulatory challenges that don’t affect other medical devices. The first is the “black-box” factor: It may be impossible to explain or understand how a given AI model comes up with an output. The second is the fact that AI can “learn.” That means a given model’s output may change as it’s being used in the field, depending on the data it’s presented with.
STAT News reviewed this complex topic this week, addressing the added uncertainty that the current administration’s across-the-board cuts of probationary employees has caused (see bird-flu article above for details).
COMMENTARY: Even in the best of times, regulating the use of AI would be challenging. The pace of innovation continues to accelerate, but regulation has not. The FDA has stated - well before the recent cuts - that it does not have the staff or skills to keep up. Recent arbitrary decimation of the agency can only delay clinical uptake. These are clearly not the best of times.
A blood test for early stroke diagnosis
When a person has a stroke, fast diagnosis and treatment are critical. And when we say diagnosis, we mean more than just realizing that a stroke is happening. Clinicians need to know whether their patient’s stroke is caused by a blood clot or a brain bleed, because the treatments for one type will kill a patient who has the other.
That distinction is currently made with imaging, which can only be done once the patient reaches a hospital. A study presented at the American Stroke Association International Stroke Conference 2025 showed that a biomarker-based blood test could one day allow EMTs to make that call much earlier.
The biomarker is glial fibrillary acidic protein (GFAP), which is released into the bloodstream when brain cells are damaged or destroyed. The study showed that GFAP levels were almost 7 times higher in patients with bleeding stroke than they were in those with clot-based stroke. They were more than 4 times higher in patients with bleeding stroke than they were in those who were having symptoms that weren’t caused by a stroke. And if levels were low enough (below 30 pg/mL), a bleeding stroke could be ruled out.