The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. Importantly, many of these devices can be tailored to fit a specific patient’s anatomy. For example, the FDA has reviewed 3D-printed knee replacements and implants for facial reconstruction.
The new guidance gives the FDA’s recommendations regarding the content of FDA submissions, device testing, and manufacturing considerations for 3D printed devices.
This guidance will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.
The new guidance comes on the heels of recent FDA approvals for several 3D-printed devices, including Medicrea’s 3D-printed titanium interbody device for spinal surgery. The FDA also recently approved a 3D-printed drug tablet, the epilepsy drug Spritam, marketed by Aprecia Pharmaceuticals.