The FDA is considering evaluating generative AI-enabled medical devices through a "competency-based approach," similar to how doctors are evaluated, the agency writes in a discussion paper first shared with Axios.

Why it matters: Emerging medical technologies are challenging the existing framework for overseeing medical devices, prompting calls for new approaches.

Driving the news: The FDA's discussion paper raises considerations for both preapproval and postmarket regulation of AI-enabled devices and solicits stakeholder feedback.

• The document isn't intended to serve as guidance for device makers and notes that the agency is still in the preliminary phase of its effort.
• "We are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation and serves as a potential model for regulators around the world," Michelle Tarver, director of the FDA Center for Devices and Radiological Health, said in a statement.

The big picture: There's been an explosion in AI-enabled health care tools directly involved in clinical care, and the regulatory structure so far hasn't kept up.

• New technologies range from information tools to devices designed to provide patient care, either with or without a doctor in the loop.
• "Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly," acting FDA commissioner Kyle Diamantas said in a statement.

Between the lines: Regulatory experts — and now the FDA — note that generative AI devices are substantially different from other regulated medical devices, particularly because of the variation in their outputs and because they evolve over time.

• That requires a shift in how the agency evaluates such devices before they're on the market and also creates a need for rigorous postmarket monitoring.

What's inside: The FDA's discussion paper begins by outlining a method for evaluating the risk of a GenAI device, measuring the type of activity performed by a device against the severity of the consequences from incorrect outputs.

• It then discusses considerations for premarket evaluation.

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The Trump administration's push to reshore drug development is becoming part of efforts to renew the user fee system that pays for reviews of new medicines.

Why it matters: "America First" incentives the administration is proposing would add a political twist to what's been a bipartisan process, but could gain favor as policymakers look for ways to reduce dependence on China.

Driving the news: The administration wants to cut FDA new drug application fees in half for companies that include data from at least one early-stage clinical trial anchored in the United States after Oct. 1, 2027.

• It also would offer a 50% reduction for applications to expand the use of an "orphan drug" for a rare condition to a second disease.
• And it would restrict eligibility for waivers exempting small businesses from application fees so that they only go to U.S. companies.

The proposals are part of a package of changes that Congress is due to take up before the FDA user fees expire in September 2027, according to a Federal Register filing last week.

• Some past efforts to shift more manufacturing and research to the U.S. have raised questions from Democrats about whether the administration is putting politics over science or could favor drug companies liked by President Trump.

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Vaccination rates among American kindergartners decreased during the 2025–2026 school year for all tracked vaccines, the CDC reported yesterday.

• Exemptions from getting one or more vaccines increased in 41 states and the District of Columbia, growing to 4.2% from 3.6% the year before.

Why it matters: The drop-off coincided with continued efforts by the Trump administration to make controversial vaccine policy changes and with measles cases hitting levels not seen in more than three decades.

By the numbers: Coverage with the MMR, DTaP, polio and varicella vaccines decreased in more than half of states, ranging from 92% for diphtheria, tetanus and acellular pertussis (DTaP) vaccine to 92.4% for the measles, mumps and rubella (MMR) and polio vaccines. Public health officials say overall measles vaccination rates should remain above 95% to maintain herd immunity.

• The number of kindergartners attending school without documentation of completing the two-dose MMR vaccine series was about 280,000 in 2025–2026, officials said.
• The number of kindergartners exempt from one or more vaccines was about 155,000.
• 24 states reported exemptions exceeding 5%.

What they're saying: The CDC, in a statement, said the data showed a 0.1% decline in vaccination coverage among children entering kindergarten — and that it continues to encourage parents to discuss vaccination options with their doctors.

Yes, but: It only takes a small drop in the vaccination rate to make herd immunity against measles plummet.

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