3D printing holds incredible potential within the healthcare field, particularly for creating medical devices quickly and cheaply. In fact, surgical instruments, prosthetics, orthopedic implants, and dental crowns have already been created with 3D printers.
3D-printed medical devices, however, raise important regulatory issues that anybody studying pharmaceutical regulatory affairs should be aware of. Health agencies, including in Canada, are beginning to provide some answers as to how 3D-printed medical devices will be regulated. Let’s take a look at the issue and how it is being managed.
3D-Printing Raises Important Questions for Students in Drug Regulatory Affairs Training
The reason 3D-printed medical devices are proving such a challenge for regulators is because anyone with a 3D printer can theoretically create a medical device. That’s because 3D printers need only a computer file containing the 3D design in order to turn the design into a real product.
This has significant benefits. For example, hospitals and clinics would be able to print their own medical devices onsite, which would mean quick delivery of devices for patients. However, it also means that individuals themselves could also print their own medical devices at home. As you’ll learn in your drug regulatory affairs courses, Good Manufacturing Processes (GMPs) are an important part of the pharmaceutical regulatory process. But verifying that GMPs are being followed is much easier when that manufacturer is an established company with factories than individuals printing devices at home.
The FDA and Health Canada Take Similar Approaches to 3D-Printed Devices
Health Canada recently issued guidance for how companies can get a medical device licence for 3D-printed medical devices. The guidance largely mirrors the U.S. Food and Drug Administration’s (FDA’s) own guidance. It applies to Class III and Class IV implantable medical devices manufactured with 3D printing. Under the guidance, manufacturers can use evidence from a comparable medical device that was manufactured using more traditional methods. This will help speed up regulatory approval for 3D-printed medical devices that are substantially similar to devices that are already on the market.
If the 3D-printed device uses a new design or new material, however, then additional evidence will need to be supplied to Health Canada by the manufacturer. For example, manufacturers will need to include a device description, which will include information about the materials used, the reason for choosing 3D printing over traditional manufacturing methods, the critical features of the device, and more. Additionally, manufacturers will need to provide data about the device’s safety, including clinical trial data, shelf life information, and software verification.
Regulators Have Yet to Tackle 3D Printing of Other Medical Devices
Health Canada has acknowledged that its current guidance is only a first step in the regulation of 3D-printed medical devices. As a result, the guidance is somewhat limited and doesn’t cover many medical devices that could be 3D-printed, including custom-made devices, drugs, and bio-printed products, such as human tissue. It’s also largely directed at companies and healthcare providers and doesn’t address the challenges posed by individuals printing medical devices on their own.
That’s not surprising since 3D-printing technology is advancing rapidly and continuously raises new issues for regulators. As a result, students in drug regulatory affairs training should expect additional guidance documents from Health Canada and other agencies in the not-too-distant future to address other 3D-printing-related issues.
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