Medical Device Right to Repair is the Wrong Approach

By Peter Pitts, Former Associate FDA Commissioner | MedCity News

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.

Read the full piece in MedCity News.