Peter J. Pitts , 2025-04-18 13:55:00
Americans are becoming more familiar with the right to repair movement that is shaking up industries from agriculture to consumer electronics. The notion is that consumers should be empowered to hire whoever they want to fix their own technologies, regardless of expertise or oversight.
In fact, as of 2025 all 50 states have proposed some form of right to repair legislation. That’s probably because on the surface, the concept promises significant benefits. However, as with many well-intentioned ideas, the proof of the pudding is in the eating.
Alas as HL Mencken said, “For every complex problem there is an answer that is clear, simple, and wrong.” The widespread implementation of right to repair presents a host of challenges that need careful consideration. From navigating complex intellectual property laws, to ensuring safety standards are met for regulated products, there are numerous hurdles that must be addressed before this movement can truly deliver on its promise.
So as state houses nationwide try to secure a win by granting greater autonomy to consumers, it is imperative that lawmakers approach the drafting of these policies with prudence and precision. Overly broad language could unintentionally undermine critical safety standards for essential products that the public depends on, such as complex medical devices.
Welcome to my world. As a former associate commissioner at the U.S. Food & Drug Administration (FDA) we oversaw regulations around health technologies and the quality standards that help manufacturers bring safe and innovative technologies to market – and keep them safe and effective. Importantly, in an era where technology plays a pivotal role in healthcare delivery and outcomes, upholding patient safety is of paramount concern.
But here lies the rub.
Manufacturers of medical devices are required to follow the highest standards — third party repair shops are not. In fact, unregulated service providers are not obligated to report any adverse events stemming from their work because they do not fall under the jurisdiction of the FDA. So, not only is there a dangerous regulatory gap, creating the legal right to repair in this space would create a life-threatening loophole. And an invisible one at that.
While right to repair laws differ across states, many proposed bills broadly cover all types of digital electronics. Such a sweeping policy that inadvertently allows unregulated repairs to FDA-regulated medical devices jeopardizes patient safety. Hence, the regular call for lawmakers to create special exemptions for medical device technology. It’s the smart move.
But now, some states have oddly adopted a deliberate focus on pairing right to repair directly with medical devices. Cui bono? Not patients.
In February, Vermont introduced a medical device-specific right to repair bill, which would encourage third party servicers to conduct device repairs at hospitals without the vetted training programs, regulatory oversight, or regular reporting requirements. In March, North Carolina introduced a similar policy, which requires the original manufacturers to give unregulated service providers their own proprietary repair information and manuals. This is a recipe for disaster.
The question we must ask is, how can physicians and patients be confident enough that vendors entirely ignorant of the FDA process for repair and reporting can properly recalibrate life-saving machines? Is this really the right place to argue that “anyone can do it?”
To make matters worse, these pieces of legislation are often confused with right to try laws, that allow terminally ill patients to access experimental drugs that have not yet been approved by the FDA. Right to try is backed by federal law. It is not the same as right to repair. Not even close.
As legislative sessions continue, lawmakers must consider the grave risks associated with dangerously broad right to repair policies and ensure medical device carveouts before it’s too late. Patient safety must come first, always. No exceptions.
Photo: Vadim Sazhniev, Getty Images
Peter J. Pitts is President of the “https://cmpi.org/”>Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine. He is a former Associate Commissioner of the US Food and Drug Administration and member of the United States Senior Executive Service.
This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.