This post originally appeared in Volume 56 of Make Magazine under the headline How to Know if the FDA Wants to Regulate Your Prototype. My contract required me to give them 3 months of exclusivity. With that up, I’m posting it here.
It’s all good fun to 3D print a DNA extraction centrifuge, make a homebrew heart rate monitor, or build an Arduino-powered bioreactor. But as you delve deeper into the world of biohacking, you may eventually wonder if (or when) the government will take an interest in what you’re doing.
There are lots of good reasons for government regulation here. When you take a drug, get a device implanted in you, or have a medical test done, it can be comforting to know that someone is ensuring that the drug isn’t poison, the device won’t explode inside you, and the medical test won’t insist that your ears are falling off (assuming that your ears aren’t actually falling off).
The Spirit of ‘76
For all of their benefits, regulations can also prevent good things from happening. Processes can be expensive to comply with and testing can take time. Small-scale participants can have trouble identifying rules relevant to them, let alone comply with them. That makes regulation, like so many things in life, a balance between safety and doing new things.
Unfortunately for DIY biohackers, the last time Congress passed a major medical device law was in 1976. Back then, only large companies had the ability to manufacture medical devices. Congress didn’t imagine that people would be making them at home. It certainly didn’t imagine that the at-home inventors would be able to distribute them to the world over the internet — and possibly do so without any commercial infrastructure.
Nonetheless, the regulatory structure of 1976 remains in force today. Devices are sorted into three tiers based on their intended use. Class I devices are regulated under “general controls,” which are generally light-touch rules designed to handle lower risk devices. Class II devices are subject to special controls because they are potentially more dangerous. Class III devices require premarket approval before being distributed. (We’re just setting the scene, but if you have specific questions about the three-tier system or about your specific device, you should speak with a lawyer.)
General Wellness vs. Medical
For our purposes, the question is not how medical devices are regulated, but rather when your project becomes a medical device that the FDA wants to regulate. The difference is between a “general wellness” device, which isn’t regulated, and a “medical” device, which is. Distinguishing between them involves two major factors.
The first is if the device is geared towards “general wellness.” The more the device is oriented towards general wellness, the less likely it is to be regulated by the FDA. General wellness is a focus on overall health instead of specific diseases. Think about jogging — it’s a healthy lifestyle choice that impacts a range of diseases, heart disease among them. But jogging isn’t a specific treatment for heart disease in the same way that prescription medication is. General wellness devices tend to measure things like fitness, sleep, concentration, heart rates, or physical impact in order to help you live a healthier lifestyle.
The second factor is whether the device poses a low risk to safety. Not surprisingly, if it doesn’t pose a safety risk, the FDA is more likely to classify it as a general wellness device. Conversely, if a device could pose a significant risk — even due to misuse — the FDA is likely to want to take a closer look. Helpfully, the FDA provides four characteristics to look for in a device, any one of which would suggest that the device poses a higher-than-low risk to safety:
- Is the product invasive (does it penetrate the skin)?
- Is the product implanted?
- Does the product use a technology that is itself risky if not regulated (think medical lasers or radioactive elements)?
- Are similar existing products regulated?
That last point is important. If you are working on a device and all of the established commercial devices in the space are regulated, the FDA will probably take a keen interest in your device as well.
What’s the takeaway here? Keep hacking and building new things. But as you start building devices that are geared toward treating specific diseases or that can do real harm if they malfunction, keep in mind that the FDA might be interested. At that point it is probably time to put down this magazine and find yourself a lawyer.
The FDA recently published guidance to help distinguish between medical devices and wellness devices.
Anna Wexler takes a deep dive into the regulations surrounding brain stimulation devices currently on the market (there’s also a longer version that’s behind a paywall). Below is a presentation she gave on the topic:
The challenges posed by DIYers entering the modern medical space has not gone unnoticed by the medical establishment. Doctor Jeremy A. Greene outlines the various concerns with DIY medical devices in the New England Journal of Medicine.
The FDA itself walks through how it approaches some of these questions in section II. B. of this workshop paper on neurodiagnostic devices.
The FDA also provides information about how it regulates medical devices here, here, and here.