When Will Medical Device Regulation Intersect With At-Home 3D Printing?

Recently it was reported that the FDA sent a letter to a mobile app developer, Biosense Technologies Private Ltd., informing them that their app product, the uChek Urine analyzer, potentially required FDA clearance as a medical device. The FDA is still planning to release final guidance on clearance requirements for the 40,000 medical apps that are out there. But what about 3D printed medical devices?

First, let’s ask: What’s a medical device according to the FDA?

  • an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” (emphasis added)

According to the FDA even a simple tongue depressor can be a medical device, so it seems to me at least likely that a 3D printed object such as a prosthetic, implant or, yes, tongue depressor could fall within this definition. And if such a printed object is labeled, promoted or used as such, then it may require FDA clearance. Here’s a 3D printable prosthetic finger available right now on Thingiverse that may or may not qualify as a medical device. So how and when will health agencies start to regulate individuals putting medical device designs on sites like Thingiverse, and people printing and using them at home?

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