Washington, D.C. –   AdvaMed, the Medtech Association, is the world’s largest trade association representing medtech companies, ranging from multinational corporations to the smallest businesses and startups. The health care system relies on FDA regulation of medtech. The FDA determines whether a medtech device may be marketed to patients and providers. A user fee agreement between FDA and medtech companies, authorized by Congress, funds part of the regulatory setup. Scott Whitaker, AdvaMed president and CEO, made the following statement on LinkedIn on news reports of significant FDA job cuts.

“Over the weekend, significant job cuts were made to FDA that could have a very negative impact on patient care in this country. Today, I sent a letter to HHS outlining our concerns.

“We understand and support the administration’s overall goal to be more efficient with the taxpayer dollar. Our concern is that this round of cuts to FDA staff runs counter to that shared goal.

“Device review times were already too long, though they were improving as the result of our latest user-fee agreement. FDA was already struggling to keep pace with our industry’s tens of thousands of new medical technology applications every year, all of which are intended to improve the lives of patients in this country. And in this regard FDA was improving as well (and also due to our latest user-fee agreement). That agreement, for the first time ever, created private sector-like incentives for FDA to be more efficient, transparent, and predictable in its review process. And this was of tremendous benefit to the patients whose lives and health depend on access to America’s leading-edge medical technologies and treatments.

“Unfortunately, as a result of these reductions, FDA will lose hundreds of new employees, the best and most innovative hires under our most recent agreement.

“But there remains time to change course. Working together, we can achieve a more efficient and effective FDA. But, on behalf of our members, I am concerned that the cuts made over the weekend not only will not accomplish that, I am also concerned that it puts at risk our nation’s status as the top medtech market in the world—as the global leader in medtech innovation, manufacturing, and jobs.

“AI in health care is a clear, illustrative example. AI is driving earlier and more accurate diagnoses, which means earlier treatments and better outcomes for patients—which, in turn, translates into lower costs to patients and to our health care system overall. Eliminating FDA’s recent critical new hires in the AI space will dramatically slow review times and require reassigning non-experts already at FDA to review these technologies who will inevitably make slower and potentially inappropriately conservative decisions.

“These cuts were planned before Secretary Kennedy was even sworn into office. I am sure this latest action would not align with his goal of making America healthy again.

“I hope we are able to work with Secretary Kennedy, his leadership team, and that of FDA to reverse these cuts, and then put our heads together on policies that will achieve the aims of President Trump and DOGE but without putting patients and America’s leadership role in medtech at risk.”