Americans are becoming familiar with the right to repair the movement that is shaking the agriculture industries to consumer electronics. The notion is that consumers must be empowered to hire whoever wants to fix their own technologies, regardless of experience or supervision.
In fact, as of 2025, the 50 states have proposed some form of right to repair the legislation. That is likely because on the surface, the concept promises significant benefits. However, as with many well -intentioned ideas, the Buddine test is in food.
Unfortunately, as HL Mencken said: “For each complex problem there is a clear, simple and incorrect response.” The generalized implementation of the right to repair presents a series of challenges that need careful consideration. From the navigation of complex intellectual property laws to ensuring that safety standards are with regulated products, there are numerous obstacles that must be borgged before this movement can really fulfill their promise.
So, as state houses throughout the country try to obtain a victory by giving greater autonomy to consumers, it is imperative that legislators address the writing of these policies with prudence and precision. The too broad language could undermine critical security standards for the essential products on which the public depends, as complex medical devices.
Welcome to my world. As a former associated commissioner of the United States Drug and Drug Administration (FDA) we supervise regulations on health technologies and quality standards that help manufacturers to carry out safe and innovative technologies to the market, and keep them safe and effective. It is important to note that, in an era in which technology plays a fundamental role in health provision and results, patient safety defense or primary concern.
But here lies the rubbing.
Medical devices manufacturers are required to follow the highest standards: third -party repairs workshops are not. In fact, non -regulated service providers are not bonds to inform that advertising events vote on their work because they do not fall under the jurisdiction of the FDA. Therefore, not only is there a dangerous regulatory gap, creating the legal right to repair in this space would create a Threat Threating escape. And an invisible one in that.
While the laws of the right to repair differ between the states, many propose invoices widely cover all types of digital electronics. Such sweeping policy that inadvertently allows repairs not regulated to the medical devices regulated by the FDA endangers the safety of the patient. Therefore, the regular call for legislators to create special exemptions for medical device technology. It is the intelligent movement.
But now, some states have strangely adopted a deliberate approach in the right to match directly with medical devices. CUI BONO? No patients.
In February, Vermont introduced a specific right of medical device to repair the invoice, which would encourage third -party administrators to perform device repairs in hospitals without training programs examined, regulatory supervision or regular reports requirements. In March, North Carolina introduced a similar policy, which requires original manufacturers to provide non -regulated service providers with patented repair manuals. This is a recipe for disaster.
The question we should ask is, how can doctors and patients have safe enough for suppliers to completely ignore the FDA process for repair and reports can copemeally recalibrate the machines that save lives? Is this really the right place to argue that “someone can do it?”
To make things worse, these pieces of legislation are often confused with the laws of the right to prove, which allow patients with terminal diseases to access experimental medications that have not yet approved the legs by the FDA. The right to try is supported by federal law. It is not the same as the right to repair. Not equally close.
As the legislative sessions continue, legislators must give the serious risks associated with the dangerously broad right to repair policies and ensure that medical devices are carved before it is too late. Patient safety should be the first, always. Without exceptions.
Photo: Vadim Sazhniev, Getty Images
Peter J. Pitts is president of the “https://cmpi.org/”> Center for Medicine in Public Interest and a Professor of Visits at the Faculty of Medicine of the University of Paris. He is former associate commissioner of the United States Drug and Food Administration and member of the United States Senior Executive Service.
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