Dr. Mehmet Oz was sworn in as the Centers for Medicare and Medicaid Services administrator on April 18, cementing his role as head of the agency that provides insurance coverage to millions of Americans.

During a ceremony at the Oval Office, Oz, a physician and former TV personality, said he wanted to “save” the nation’s public health programs and focus on reducing chronic disease, “modernizing” Medicare and Medicaid, and targeting fraud, waste and abuse in government insurance offerings. 

President Donald Trump reiterated that Republicans wouldn’t cut Medicare or Medicaid. “Just as I promised, there will be no cuts. We’re not going to have any cuts. We’re going to have only help,” he said during the ceremony.

Read more here.

A draft budget document shows the Trump administration’s plan to slash funding to the Department of Health and Human Services includes substantial cuts to the Food and Drug Administration. 

The preliminary budget sets a total of $2.9 billion in requested congressional appropriations for the FDA, according to Steven Grossman, the former executive director of Alliance for a Stronger FDA, and a copy of the document viewed by MedTech Dive. That would be a roughly 18.6% decrease from $3.6 billion in budget authority the FDA received in its 2024 fiscal year. The 2024 FDA budget also included about $3.3 billion in industry user fees.

The fiscal 2026 budget must be passed by Congress and could look different from the current proposal.

User fees, which are collected by the FDA from drug and medical device manufacturers, are expected to continue through the 2026 fiscal year, according to Grossman’s reading of the document. User fees made up nearly 44% of the Center for Devices and Radiological Health’s $791.4 million budget in fiscal 2024.

The document claims the preliminary budget would provide “sufficient budget authority levels to meet statutory requirements necessary for FDA to collect medical product user fees in support of its premarket review activities.”

Read more here.

The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced April 17.

Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.

Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.

Read more here.

A week after declaring “Liberation Day” and levying hefty tariffs on most of the country’s trading partners, President Donald Trump reversed course on April 9, announcing he would pause most reciprocal tariffs for 90 days.

On its face, the pause is good news for the healthcare industry, as it offers companies some breathing room in which to make supply chain adjustments, analysts told Healthcare Dive.

However, analysts cautioned that the pause won’t last forever, and said providers and medtech companies remain under urgent pressure to reconsider their supply chains.

“The situation right now, this moment, is better than it was 24 or 36 hours ago, but there’s still plenty of gray clouds,” said Mark Pascaris, senior director and analytic lead of nonprofit healthcare at Fitch Ratings.

Read more here.

AdvaMed and nine other healthcare organizations have continued to pressure the White House to exempt medical devices and critical supplies from the Trump administration’s ongoing tariff saga.

AdvaMed, one of the largest medical device industry groups, and organizations including the American Dental Association, the Association of American Medical Colleges and America’s Essential Hospitals sent a letter on April 1 to the White House’s top trade negotiator. They outlined multiple concerns about the effects tariffs will have on the healthcare industry, such as disrupting the supply chain and increasing costs of devices and dental equipment.

“This ultimately places further financial pressure on providers, hospitals, and health systems,” the letter stated, “particularly those located in rural and medically underserved areas.”

Read more here.

Research universities won an extended reprieve April 4 when a federal judge permanently barred the National Institutes of Health from capping funding for indirect research costs at a 15% rate, a move that would cost institutions billions a year. 

U.S. District Judge Angel Kelley ruled NIH had violated federal statute, was “arbitrary and capricious” in creating the cap, failed to follow rulemaking procedures when doing so and violated constitutional prohibitions on applying new rules retroactively. 

The permanent injunction came in response to NIH’s request earlier on April 4 for a final judgment in the case so as to expedite the appeals process — meaning litigation is very likely to continue.

Read more here.

A Senate committee hearing involving Health and Human Services Secretary Robert F. Kennedy Jr. won’t happen on April 10 as initially proposed by the panel’s leading lawmakers, who are seeking answers on the deep-cutting restructuring of the health department that Kennedy ordered in March. 

Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., sent an invitation to Kennedy on April 1, the same day layoff notices went out to thousands of federal health workers across the Food and Drug Administration, Centers for Disease Control and Prevention and other agencies overseen by the HHS.

In their letter, Cassidy and Sanders asked Kennedy to give an update on the reorganization to the Senate Committee on Health, Labor and Pensions on April 10. However, hearings must be scheduled at least seven days prior, and as no official notice has gone out, the proposed hearing won’t take place on April 10.

Read more here.

Employees who were supposed to receive layoff notices didn’t get them. Notices that did go out had the wrong office name, or specified an office that no longer exists. Some employees were told that, if they had discrimination complaints, to reach out to an equal opportunity office director who died last year.

The broad reduction in force for the Department of Health and Human Services, which agency head Robert F. Kennedy Jr. ordered in late March, began April 1. It was a mess, according to many sources who worked across the large federal health department.

Thousands of civil servants, from low-level staffers to leaders, were cut across multiple HHS agencies, including the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health and the Centers for Medicare and Medicaid Services.

Read more here.

Employees at the Food and Drug Administration’s medical device center on April 1 received notice that they would be cut amid massive layoffs at federal health agencies.

The reductions included people who work in communications and records requests; regulatory programs and administrative services; and other functions, according to two FDA employees and one person who was laid off from the agency. All three spoke to MedTech Dive on the condition of anonymity.

The layoffs followed a weekend of uncertainty and stress for federal workers about their future job status. The Department of Health and Human Services announced in late March that it would cut 10,000 full-time employees, including 3,500 FDA workers.

People working at the agency said it was an emotional day, with uncertainty about more cuts ahead. 

“Everyone has very low morale. It’s just brutal,” said a product reviewer at the FDA. “People with 15-20 years of service are just gone.”

Read more here.

A Texas federal court on March 31 struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry.

Judge Sean Jordan, for the U.S. District Court for the Eastern District of Texas, vacated the FDA’s final rule in its entirety. The court remanded the matter to newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr.

The FDA’s final rule was vehemently opposed by the laboratory industry, which argued it would slow development of critical diagnostics and force labs to scale back the number of tests they could perform, decreasing patient access to care.

“This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country,” ACLA President Susan Van Meter said in a statement on March 31.

Read more here.

Health and Human Services secretary Robert F. Kennedy Jr. plans to dramatically reshape the department he leads through mass layoffs and consolidation of the sprawling agency that provides health insurance to tens of millions of Americans, responds to disease outbreaks and regulates medical products.

About 10,000 full-time employees at the department will be let go under Kennedy’s plans, which were announced March 27. The planned terminations are in addition to the roughly 10,000 or so employees who have already left the HHS through other Trump administration efforts, such as offers of early retirement. All told, the department will shrink in size by about 25% to about 62,000 full-time employees.

The Food and Drug Administration, which houses the Center for Devices and Radiological Health, will lose about 3,500 full-time employees, according to the HHS. The department said the “reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.”

AdvaMed, one of the medical device industry’s largest lobbying groups, said in a March 27 statement that the organization agrees with Kennedy’s goal to ensure the HHS and other federal health agencies are more “efficient and accountable.”

Read more here.

The U.S. Senate on March 25 confirmed Johns Hopkins University surgeon Martin Makary to be Food and Drug Administration commissioner, giving him authority over an agency that regulates a wide swath of the U.S. economy that includes food, tobacco, drugs and medical devices.

Three Democrats joined 53 Republicans to confirm Makary in a 56-44 vote. Sen. Bernie Sanders, the senior minority member of the Senate Health, Education, Labor and Pensions Committee, voted no.

Makary will be under pressure to change the FDA’s direction on some drug regulation issues in response to guidance from President Donald Trump and new Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic. Direct-to-consumer drug advertising could receive renewed scrutiny, although Trump failed to ban it in his first administration. Trump has also raised concerns about the role of pharmaceuticals in chronic disease trends, the topic of a recent closed-door federal commission meeting.

Read more here.

The Environmental Protection Agency plans to reconsider emissions standards for facilities that sterilize medical devices as part of a broader deregulatory agenda announced on March 12.

The Trump administration is considering a two-year compliance exemption for affected facilities while the EPA goes through the rulemaking process, the agency said in the announcement. Last year, the EPA released a final rule limiting emissions of ethylene oxide, a carcinogenic chemical used to sterilize about half of medical devices in the U.S. 

Read more here.

Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of agency staffing if confirmed but didn’t offer any views on the appropriateness of layoffs ordered by the Department of Government Efficiency.

At a Senate confirmation hearing on March 6, the Johns Hopkins University surgeon said he wasn’t involved in decisions to fire hundreds of FDA employees, but vowed to make sure that the staff has “all the resources they need to do their job well.”

Read more here.

Many people who were fired from the Food and Drug Administration’s medical device center in mid-February had their termination letters rescinded over the weekend, according to AdvaMed and three FDA employees who spoke on condition of anonymity. 

The three people working at the Center for Devices and Radiological Health said they received calls over the weekend asking them to come back. They received follow-up emails from the FDA confirming their IT and security access had been restored.

Read more here.

AdvaMed CEO Scott Whitaker warned the Department of Health and Human Services that job cuts made over the weekend at the Food and Drug Administration could have a “very negative impact” on patient care and threaten the country’s position as the world’s medtech industry leader.

Whitaker, in a Feb. 18 LinkedIn post, wrote that “significant” cuts to the FDA’s staff were planned before Robert F. Kennedy Jr. was sworn into office as HHS Secretary. The round of cuts does not align with Kennedy’s goal of making America healthy again, Whitaker wrote.

Whitaker spelled out his concerns in a letter to the HHS.

The cuts at the FDA come as President Donald Trump carries out a large-scale plan to reduce the federal workforce through a newly named Department of Government Efficiency led by businessman Elon Musk, the world’s richest person and a Trump adviser.

Read more here.

A federal judge on Feb. 11 ordered the Food and Drug Administration and other federal health agencies to restore websites that were removed in response to executive orders from President Donald Trump, writing that the move harmed underprivileged Americans.

District Judge John Bates ordered the FDA, Centers for Disease Control and Prevention and Department of Health and Human Services to restore the removed websites listed in the lawsuit by midnight Feb. 11, including sites on diversity and the study of sex differences in clinical trials. As of Feb. 12, the pages had been restored.

Read more here.

The Trump administration on Feb. 11 directed federal agencies to “undertake plans for large-scale reductions in force” as part of a sweeping plan to shrink the size of the U.S. government.

The executive order instructed agency heads to coordinate their plans with the Department of Government Efficiency, the cost-cutting initiative led by Elon Musk, one of President Donald Trump’s closest advisers and the world’s richest person.

The order tasked agencies to prioritize for layoffs all temporary employees and any staff of offices not “mandated by statute or other law.” Additionally, the order laid the groundwork for a policy limiting hiring to no more than one employee for every four that leave their positions.

Read more here.

AdvaMed, one of the largest medical device trade groups, told the Trump administration it is concerned about the potential impact of tariffs on the medical technology supply chain and wants an exemption for the industry.

CEO Scott Whitaker said tariffs affect U.S. companies like an excise tax. The impact could lead to less R&D and innovation, layoffs and higher prices for payers and patients. 

President Donald Trump has said companies can avoid the impact of tariffs by manufacturing in the U.S. Whitaker said relocating manufacturing requires Food and Drug Administration approval, making it difficult to move production to the U.S. in the short term.

“We have shared with the Administration our concerns about the potential impact tariffs could have on the medical technology supply chain that American patients depend on for their care,” Whitaker said in a statement.

Read more here.

Troy Tazbaz, director of the Food and Drug Administration’s Digital Health Center of Excellence, said in a Jan. 31 LinkedIn post that he is leaving the agency effective immediately. 

Tazbaz led the digital health center for two years, guiding the FDA’s policymaking on artificial intelligence and software as a medical device. 

Read more here.

Two days into the Trump administration, several webpages covering diversity in clinical trials, annual medical device reports and LGBTQ+ information were removed from the Food and Drug Administration’s website.

When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and Human Services. The HHS did not respond to multiple requests for comment. 

“It is definitely not typical,” said Diana Zuckerman, president of the National Center for Health Research. “From one administration to another, certain things are reviewed and taken down. I don’t think ever [in] the first week of the administration.” 

Read more here.

Sara Brenner, a Food and Drug Administration official overseeing medical devices, was named the agency’s acting commissioner, according to an update to the regulator’s leadership bio page.

Read more here.