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.

Learn More

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.

SMK Front

This post originally appeared on the Shapeways blog.

Today we are excited to announce a special jewelry contest in partnership with the National Gallery of Denmark. The contest gives the Shapeways design community a chance to have their jewelry displayed and sold in Copenhagen.

The National Gallery (known by its Danish initials, SMK) is a leader in the OpenGLAM movement. OpenGLAM promotes open access to cultural works in galleries, libraries, archives, and museums. SMK Open makes sure that works in SMK’s collection that are in the public domain (i.e., no longer protected by copyright) can easily be accessed and built upon by the public without restrictions.

SMK Matrix

The curators at SMK have selected six paintings in the public domain — including masterpieces by Cranach, Gijsbrechts, and Hammershøi — to serve as the inspiration for this contest. Designers can use these works as jumping-off points to create unique 3D printable jewelry. Since the works are not protected by copyright, designers are free to use whatever parts of the works they wish.

One winner and four runners-up will be displayed at SMK for the month of September 2017. These designs will also be eligible for sale in SMK’s gift shop. A panel of judges, including representatives from SMK and Shapeways, will select the winners.

All you need to do to enter is to design a new piece of jewelry based on one (or more than one) of the works, upload it to a public Shapeways shop, and tag it SMK.

But you had better hurry: The contest ends June 16, 2017.

To enter the contest, study the paintings, and read the complete rules, visit the SMK Collection Jewelry Design Contest page.

This post originally appeared on the Shapeways blog.

This week, Shapeways is proud to join over 800 of our fellow startups and tech companies in support of net neutrality. Our letter to the chairman of the U.S. Federal Communications Commisson, Ajit Pai, reiterates the importance of a fair, open internet to Shapeways and the entire Shapeways community.

This letter is necessary because Pai has indicated interest in rolling back the landmark open internet rules established by the FCC in 2015. Those rules formalized the protections that allowed for the growth of the internet that we know today.

Shapeways has long supported net neutrality because we understand how critical an open internet is to our success and to the success of every Shapeways user. Shapeways started as a small company in the Netherlands based on a technology that few people had heard of. We were in no position to cut deals and make special payments to big internet service providers just to be able to reach our customers. Net neutrality allowed us to grow as our community grew, not as gatekeeper internet service providers would let us grow.

The independent shop owners, makers, and creators that make up the Shapeways community rely on an open internet as well. They reach their fans, customers, and collaborators without having to worry about what the company that connects them to the internet thinks about their activity.

We hope that our letter will remind Pai of the importance of net neutrality and help convince him not to overturn these critical rules. We thank Engine, Techstars, and Y Combinator for helping to organize this letter, our colleagues for joining it, and all of the organizations and individuals who have fought — and will continue to fight — for an open internet. We understand that includes many members of our community, who we will keep you updated as this process continues to evolve.

This post originally appeared in the Shapeways blog.

Today, Shapeways joined with a number of other online platforms to submit a letter to the European Parliament. The letter raised our collective concerns about new online copyright proposals that the Parliament is currently considering. Specifically, we are concerned that a new proposal would erode or eliminate the safe harbors that allow online platforms like Shapeways to serve our users.

This proposal is in Article 13 of the proposed Digital Single Market Directive. As you may recall, online platforms such as Shapeways operate within what is known as a copyright safe harbor. That safe harbor allows us to trust that the content uploaded by our users does not violate anyone else’s copyright interest until and unless we hear from that anyone else. In the USA, this safe harbor is part of the Digital Millennium Copyright Act or DMCA (we’ve been talking about the DMCA in a slightly different context here, and you can learn how the DMCA process works in practice on Shapeways here). In the EU, it is part of the E-Commerce directive.

As originally written, the proposed Article could impose an obligation to create some sort of new copyright filtering technology, report the activity of our users to large rightsholders, and give large rightsholders control over what kinds of new services are created.

Fortunately, the EU policymaking process is a process, which means that the initial proposal is not necessarily the final version of the rule. Since the release of the original proposal, various committees have proposed changes and suggestions to the text.

While some of these proposals are improvements (for example, recognizing that users of online platforms are key stakeholders in the rules that govern online platforms), we are still skeptical that the changes are necessary at all. That is why we conclude our letter by urging policymakers to maintain the integrity of the safe harbors that have allowed so much creativity to flourish.

The Parliament now moves into a deeper discussion phase. We will continue to monitor the discussion, and provide updates as they become available.

This post originally appeared in the Shapeways blog.

Today the U.S. Supreme Court handed down a decision in the cheerleader uniform case we have been tracking for the past few years. The decision clarifies the test used to determine how copyright applies to many 3D printed objects. While it is too early to say for sure, it likely also greatly expands the scope of copyright protection for those objects.

Why should the 3D printing community care about a case involving cheerleader uniforms again? Because the case is really about a question that comes up often in the world of 3D printed objects. Intellectual property law basically divides the world up into artistic objects that are eligible for copyright protection and functional/useful objects that are eligible for patent protection. This binary division works well when an object is clearly purely artistic (like Joaquin Baldwin’s Mobius Nautalis)…

…or clearly purely functional (like Pinhole Printed’s film spool adapter).

It does not work as well when an object combines artistic and functional elements (like — of course — Studiogijs’ Birdsnest Egg Cup).

Prior to today, there were over ten tests for how to handle these types of objects. Each of these tests tried to figure out what part of the object, if any, was eligible for copyright protection. Remember that copyright protection can last the life of the creator plus 70 years after her death. That means that the difference between an object being protected by copyright and an object not being protected by copyright has repercussions for generations.

The Decision

The decision itself sweeps away those multiple tests for how to handle mixed objects and replaces it with what will hopefully be a fairly straightforward, two-part test:

  1. Can the artistic parts of the object be perceived as a two- or three- dimensional work of art separate from the useful article?
  2. If yes, would the artistic parts qualify for copyright protection?

If part of a mixed object passes both of those tests then those parts of the object are protected by copyright. Importantly, it is only those parts of the object that are artistic that are protected.  Nothing about this test pulls the entire object into copyright protection. That means that the fact that Smart Design’s Light Switch has antlers that are eligible for copyright protection does not mean the (purely functional) switch plate is also protected.

This test comes with an interesting corollary, which might help explain why it is such a big deal. The test does not care if removing all of the artistic elements from the object allows the remaining object to keep functioning. In other words, it is not a problem if removing the artistic elements from the object would render it functionally useless.

Since we’ve been using it as an example for a while, let’s go back to Studiogijs’ Birdsnest Egg Cup to explain why this is important.

The test as established by the Court can be thought of as a copyright-first test. Looking at the cup, it asks a viewer to pull out all of the parts of the cup that could be perceived as a two- or three-dimensional work of art. Viewed some ways, that’s basically the entire cup. The bird and the branches could all exist as an independent artistic work, even though removing them would leave you with no way to hold your egg. And that’s ok. The test does not care that there might be very little left of the functional parts of the object after you remove those artistic elements. It only cares that the artistic elements can be perceived. Each of those artistic elements are protected by copyright.

An alternative test — one not adopted by the court— could have taken a useful-first approach. Instead of starting with the artistic elements, it could have pulled out the parts of the object that are required for the object to achieve its functional goals. Again, that’s basically the entire cup. The branches, however artistically rendered, also serve the functional purpose of holding the egg. The test could then look at what was left — in this case, that’s basically the bird — and protect those with copyright. This approach would keep functional elements outside of copyright protection and greatly reduce the cup’s connection with copyright.

As you can see, the place where you start this test can have a huge impact on the outcome. Start by removing the artistic elements without concern for the underlying utility and you end up with a lot of stuff protected by copyright. Start by removing the useful parts without concern for the artistic elements and you end up with less stuff protected by copyright.

The Supreme Court decided to start with artistic elements. That makes the process for understanding what parts of mixed objects are protected by copyright a much easier one than before. It also greatly expands the number of mixed objects that are at least partially protected by copyright.

What will that mean in practice? It is hard to say. Copyright can be used as a shield by creators to prevent unauthorized copying of their work. It can also be used as a sword against them because all creation requires building on existing elements in the world. If more of those elements are protected by copyright, it may be harder to create new things without having to get permission first.

This decision came down today so we cannot be sure how it will ultimately play out. We can be sure that we will keep an eye on this and continue to provide updates here on the blog. 

Note that, unlike the rest of this post (and the blog more generally) the images in this post are not licensed under any CC license.  They are used here in compliance with the Shapeways Terms and Conditions.