FDA's Device Unit Faces Challenges Amid AI and Brain-Computer Interface Advancements

From AI to Musk's Brain Chip, the F.D.A.'s Device Unit Faces Rapid Change

There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it. Medical device technology is now deeply entrenched in many patients' health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration. Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.'s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren's wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny. More broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry's influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division's mission in the coming years. Among the issues Dr. Tarver will encounter: Brains, computers and Elon Musk Few devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise -- and return function to people who have lost it. Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right. The medical device division is playing a crucial role in this field by authorizing and overseeing trials that evaluate the devices' safety and effectiveness and, at some point in the future, deciding whether they can be sold. Perhaps no company developing a device is more high-profile than the billionaire Elon Musk's Neuralink. It is developing the brain-computer device that enabled an Arizona man to play video games with his mind. Neuralink is also beginning work on a device that Mr. Musk hopes could restore vision. Mr. Musk has emerged as a vocal supporter of former President Donald J. Trump, rallying crowds on the campaign trail and donating about $118 million toward Mr. Trump's election. He has also criticized the F.D.A. during campaign events, railing incorrectly about the agency's failure to approve a drug that cured a friend's mother's brain cancer. It turns out that the drug Mr. Musk named had been approved in 2021, as STAT news first reported. "Overregulation kills people," Mr. Musk told an audience in Pittsburgh earlier this month, going on to say that "simply expediting drug approvals at the F.D.A., I think, will save millions of lives." Neuralink has already received the green light from the agency to implant its device, which is inserted in a quarter-width hole bored into the skull, in a second patient. Depending on the outcome of the presidential election, Mr. Musk could gain considerable sway across several federal agencies overseeing his businesses, including Tesla, SpaceX and presumably Neuralink, which could give him leverage over competitors. The weight of industry influence Another agency critic, Robert F. Kennedy Jr., has joined the Trump campaign and publicized his opposition to many of the F.D.A.'s regulatory duties. He has been exceptionally vocal about the agency's funding, denouncing the agreements that funnel billions of dollars in industry money into the agency. He is not wrong: So-called industry user fees make up about half the F.D.A.'s budget. In two years, Dr. Tarver is expected to take the lead in the next set of high-stakes negotiations that determine how the F.D.A. spends billions of dollars collected from the drug and device industries that the agency regulates. The negotiations have grown in importance to the F.D.A., with industry funds now providing $362 million or nearly half of the device division's budget of $790 million, and an overall payment that amounts to nearly half of the agency's annual budget of $7.2 billion. The process is akin to the Olympics of policymaking for the F.D.A., culminating in agreements that must by passed by Congress to keep the agency running. The funds support the hiring of hundreds of agency employees who are assigned to maintain a brisk pace of product reviews. The arrangement has its supporters, who note that the money allows the F.D.A. to be competitive in hiring scientists who can keep up with the rapid flow of innovation in biotechnology and other fields. But it has also drawn criticism over concerns that it puts the F.D.A. to work for largely for-profit industries and compromises the agency's efforts to protect public health. Lingering ethics issues Those concerns loom a bit larger as Dr. Tarver steps into the post of the outgoing device division director, Dr. Shuren. He has overseen and taken part in the negotiation process with a legal client of his wife's often at the bargaining table, The New York Times found. An investigation by The Times published in August found that Dr. Shuren failed to follow agency ethics rules in some instances when his work overlapped with that of his wife, Allison Shuren, a prominent lawyer at the Washington, D.C., office of Arnold & Porter. The findings prompted lawmakers to seek a review by the inspector general of the Department of Health and Human Services. One of Ms. Shuren's clients in recent years has been Alcon, a giant in eye care that makes medical devices, including lenses implanted in the eye and lasers used in eye surgery. During user-fee meetings in 2021, Alcon executives negotiated with the F.D.A. on behalf of two medical device trade groups representing hundreds of companies. It was the only company that sent two representatives, even though it is far smaller than some others, like Medtronic and Johnson & Johnson, that were at the table. Dr. Shuren negotiated in person with Alcon and other companies in 2016, agency records show. After each cycle of talks, Dr. Shuren presented the agreement to Congress, according to agency transcripts of his testimony. Federal ethics laws bar officials from working on government matters where a spouse has a financial interest that affect one company or a discrete group. The F.D.A. has said that Dr. Shuren has "not participated in matters specific to Alcon." Asked about whether the agency had concerns about the potential for ethical and financial conflicts given Dr. Shuren's involvement in the talks, the agency declined to comment. Dr. and Ms. Shuren did not respond to requests for comment. Steven Smith, an Alcon spokesman, did not respond directly to questions, saying that "uncompromising commitments to patient health and safety and corporate integrity guide every action we take." Ethics experts said that even if Dr. Shuren weren't focused on Alcon-specific policies, he should have considered the appearance of bias in favor of a spouse's client during a wide-ranging negotiation. "A federal official's job is to instill trust in government," said Richard Painter, a University of Minnesota law professor and former federal ethics lawyer. Agreements reached in the deal-making in recent years include an F.D.A. commitment to decide approvals on 95 percent of low- to moderate-risk devices within 90 days. Another agreement led to a Third Party Review program that allows outside companies to make initial product device approval decisions that are finalized by the agency. The ballooning field of A.I. The rapid clip of product authorizations has brought the division under scrutiny in the most traditional quarters of medicine and in the most advanced. Harvard researchers recently reviewed dozens of cardiology device recalls and found that the F.D.A. had deemed many of the devices to be of moderate risk, though they turned out to be deadly. An editorial by Dr. Ezekiel Emmanuel, a former federal health official and vice provost at the University of Pennsylvania, accompanied the article and called on the F.D.A. to place safety over speed. The F.D.A. said that it disagreed with an assertion in the study that devices similar to those already marketed need to be thoroughly tested in people. Doctors and researchers vetting agency-cleared artificial intelligence programs have also found the agency's review records lacking. As they consider using such tools in patient care, a lot of answers they seek about how the programs work are nowhere to be found in agency approval records. A vast majority of those programs are considered low or moderate risk, and hundreds have been authorized under the agency's 510(K) program, in which products are typically authorized in 90 days. They include software programs meant to spot cancers and other problems on M.R.I.s, CT scans and other images. Researchers from Stanford published a study in October noting that a vast majority -- 96 percent of nearly 700 -- of artificial intelligence programs authorized by the F.D.A. had no information about race or ethnicity, "exacerbating the risk of algorithmic bias and health disparity." Researchers from Mass General Brigham and elsewhere published a report concluding that information from the F.D.A. about the performance of certain programs was too sparse to justify using in medical practice. Still, the promise of A.I. in health care has generated sky-high interest, and the F.D.A. has discussed its use in drug development and employing it internally to catch "cheating" in product applications, Dr. Robert Califf, the agency's commissioner, said in a speech at a conference in Las Vegas in October. Dr. Shuren has often said the regulatory framework for medical devices was developed for technology dating to his grandmother's time, nearly 50 years ago. At that Las Vegas venue, Dr. Califf acknowledged the agency's limitations in regulating the vast reach of A.I. programs, including how they function when they are broadly deployed. Evaluating the scope of A.I. programs extends far beyond the agency, he said. "It's so bad," he explained. "If you said: 'Well, the F.D.A. has got to keep an eye on 100 percent of it,' we would need an F.D.A. two to three times bigger than it currently is."

From AI to Musk's brain chips, the FDA's device unit faces rapid change

Medical device technology is now deeply entrenched in many patients' health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.There are now artificial intelligence programs that scan MRIs for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it. Medical device technology is now deeply entrenched in many patients' health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration. Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the FDA's device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Shuren's wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny. More broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry's influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division's mission in the coming years. Among the issues Tarver will encounter: Brains, Computers and Elon Musk Few devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise -- and return function to people who have lost it. Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right. The medical device division is playing a crucial role in this field by authorizing and overseeing trials that evaluate the devices' safety and effectiveness and, at some point in the future, deciding whether they can be sold. Perhaps no company developing a device is more high-profile than billionaire Elon Musk's Neuralink. It is developing the brain-computer device that enabled an Arizona man to play video games with his mind. Neuralink is also beginning work on a device that Musk hopes could restore vision. Musk has emerged as a vocal supporter of former President Donald Trump's, rallying crowds on the campaign trail and donating about $118 million toward Trump's election. He has also criticized the FDA during campaign events, railing incorrectly about the agency's failure to approve a drug that cured a friend's mother's brain cancer. It turns out that the drug Musk named had been approved in 2021, as STAT news first reported. "Overregulation kills people," Musk told an audience in Pittsburgh in October, going on to say that "simply expediting drug approvals at the FDA, I think, will save millions of lives." Neuralink has already received the green light from the agency to implant its device, which is inserted in a quarter-width hole bored into the skull, in a second patient. Depending on the outcome of the presidential election, Musk could gain considerable sway across several federal agencies overseeing his businesses, including Tesla, SpaceX and presumably Neuralink, which could give him leverage over competitors. The Weight of Industry Influence Another agency critic, Robert F. Kennedy Jr., has joined the Trump campaign and publicized his opposition to many of the FDA's regulatory duties. He has been exceptionally vocal about the agency's funding, denouncing the agreements that funnel billions of dollars in industry money into the agency. He is not wrong: So-called industry user fees make up about half the FDA's budget. In two years, Tarver is expected to take the lead in the next set of high-stakes negotiations that determine how the FDA spends billions of dollars collected from the drug and device industries that the agency regulates. The negotiations have grown in importance to the FDA, with industry funds now providing $362 million or nearly half of the device division's budget of $790 million, and an overall payment that amounts to nearly half of the agency's annual budget of $7.2 billion. The process is akin to the Olympics of policymaking for the FDA, culminating in agreements that must by passed by Congress to keep the agency running. The funds support the hiring of hundreds of agency employees who are assigned to maintain a brisk pace of product reviews. The arrangement has its supporters, who note that the money allows the FDA to be competitive in hiring scientists who can keep up with the rapid flow of innovation in biotechnology and other fields. But it has also drawn criticism over concerns that it puts the FDA to work for largely for-profit industries and compromises the agency's efforts to protect public health. Lingering Ethics Issues Those concerns loom a bit larger as Tarver steps into the post of the outgoing device division director, Shuren. He has overseen and taken part in the negotiation process with a legal client of his wife's often at the bargaining table, The New York Times found. An investigation by the Times published in August found that Shuren failed to follow agency ethics rules in some instances when his work overlapped with that of his wife, Allison, a prominent lawyer at the Washington, D.C., office of Arnold & Porter. The findings prompted lawmakers to seek a review by the inspector general of the Department of Health and Human Services. One of Allison Shuren's clients in recent years has been Alcon, a giant in eye care that makes medical devices, including lenses implanted in the eye and lasers used in eye surgery. During user-fee meetings in 2021, Alcon executives negotiated with the FDA on behalf of two medical device trade groups representing hundreds of companies. It was the only company that sent two representatives, even though it is far smaller than some others -- such as Medtronic and Johnson & Johnson -- that were at the table. Jeffrey Shuren negotiated in person with Alcon and other companies in 2016, agency records show. After each cycle of talks, Shuren presented the agreement to Congress, according to agency transcripts of his testimony. Federal ethics laws bar officials from working on government matters where a spouse has a financial interest that affect one company or a discrete group. The FDA has said that Shuren has "not participated in matters specific to Alcon." Asked about whether the agency had concerns about the potential for ethical and financial conflicts given Shuren's involvement in the talks, the agency declined to comment. the Shurens did not respond to requests for comment. Steven Smith, an Alcon spokesperson, did not respond directly to questions, saying that "uncompromising commitments to patient health and safety and corporate integrity guide every action we take." Ethics experts said that even if Jeffrey Shuren weren't focused on Alcon-specific policies, he should have considered the appearance of bias in favor of a spouse's client during a wide-ranging negotiation. "A federal official's job is to instill trust in government," said Richard Painter, a University of Minnesota law professor and former federal ethics lawyer. Agreements reached in the deal-making in recent years include an FDA commitment to decide approvals on 95% of low- to moderate-risk devices within 90 days. Another agreement led to a Third Party Review program that allows outside companies to make initial product device approval decisions that are finalized by the agency. The Ballooning Field of AI The rapid clip of product authorizations has brought the division under scrutiny in the most traditional quarters of medicine and in the most advanced. Harvard University researchers recently reviewed dozens of cardiology device recalls and found that the FDA had deemed many of the devices to be of moderate risk, although they turned out to be deadly. An editorial by Dr. Ezekiel Emmanuel, a former federal health official and vice provost at the University of Pennsylvania, accompanied the article and called on the FDA to place safety over speed. The FDA said it disagreed with an assertion in the study that devices similar to those already marketed need to be thoroughly tested in people. Doctors and researchers vetting agency-cleared AI programs have also found the agency's review records lacking. As they consider using such tools in patient care, a lot of answers they seek about how the programs work are nowhere to be found in agency approval records. A vast majority of those programs are considered low or moderate risk, and hundreds have been authorized under the agency's 510(k) program, in which products are typically authorized in 90 days. They include software programs meant to spot cancers and other problems on MRIs, CT scans and other images. Researchers from Stanford University published a study in October noting that a vast majority -- 96% of nearly 700 -- of AI programs authorized by the FDA had no information about race or ethnicity, "exacerbating the risk of algorithmic bias and health disparity." The agency said the publicly released summaries criticized in the study were merely brief descriptions that did not reflect the extent of staff reviews that can amount to thousands of pages about the software programs. Researchers from Mass General Brigham and elsewhere published a report concluding that information from the FDA about the performance of certain programs was too sparse to justify using in medical practice. Still, the promise of AI in health care has generated sky-high interest, and the FDA has discussed its use in drug development and employing it internally to catch "cheating" in product applications, Dr. Robert Califf, the agency's commissioner, said in a speech at a conference in Las Vegas in October. Jeffrey Shuren has often said the regulatory framework for medical devices was developed for technology dating to his grandmother's time, nearly 50 years ago. At that Las Vegas venue, Califf acknowledged the agency's limitations in regulating the vast reach of AI programs, including how they function when they are broadly deployed. Evaluating the scope of AI programs extends far beyond the agency, he said. "It's so bad," he said. "If you said, 'Well, the FDA has got to keep an eye on 100% of it,' we would need an FDA two to three times bigger than it currently is."