3D Printing: FDA Finalizes Guidance for Medical Devices

The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance "will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology."

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a "leap-frog" guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

Looking forward, Gottlieb said the technology could one day be used to treat burn patients by 3D printing their own skin cells directly onto their wounds or to grow replacement organs.

Gottlieb also said the agency is working to establish a "more comprehensive regulatory pathway" that can keep pace with manufacturing advances.

On the pharmaceutical side, Gottlieb pointed to FDA's recent approval of the first 3D printed drug, Aprecia Pharmaceuticals' seizure drug Spritam (levetiracetam), and touted work being done by scientists at the Center for Drug Evaluation and Research to better understand how 3D printing can impact inactive ingredients and other drug components.

FDA, Statement