The FDA has issued guidance for the creation of medical devices using 3D printing, as well as the Center for Devices and Radiological Health’s role in regulating 3D printed medical devices.
Orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics, are a few of the medical devices the FDA listed. To date, the FDA has approved more than 85 medical devices created by 3D printing.
But medical devices aren’t the only use for 3D printing in the pharmaceutical industry. In March, the FDA approved Aprecia Pharmaceuticals’ SPRITAM® (levetiracetam), which was the first FDA-approved drug manufactured using 3D printing.
With numerous applications for this growing technology, the FDA endeavors to identify its role in regulating 3D-printed products. The respective regulatory groups for products created using 3D printing are as follows:
- Medical devices are regulated by FDA’s Center for Devices and Radiological Health (CDRH)
- Biologics are regulated by FDA’s Center for Biologics Evaluation and Research
- Drugs regulated are by FDA’s Center for Drug Evaluation and Research
The FDA issued draft guidance in 2016, titled “Technical Considerations for Additive Manufactured Devices,” which provides guidance for manufacturers who are producing devices through 3D printing techniques. Manufacturers are advised on device design, manufacturing, and testing considerations.
According to the FDA: “[t]he use of 3D printing is not limited to medical devices. Other industries and government departments are also interested in its use. For instance, the Department of Energy (DOE) is investing resources to study 3D printing, and how it can be used to reduce waste by using fewer raw materials and require fewer manufacturing steps.”