Final guidance on medical device additive manufacturing, also known as 3D printing, has been released by the US Food and Drug Administration (FDA). The guidance finalises the draft guidance from May 2016, however, the recommendations and considerations remain largely intact.
A few changes in the final guidance include cybersecurity considerations for patient-matched devices and new information on handling complex design files.
The FDA has released the guidance to help device manufacturers on technical aspects of additive manufacturing and to clarify what the agency recommends to include in submissions for 3D-printed medical devices. The guidance also comprises information on various approaches to 3D printing, such as device design, testing of products for function and durability, and quality system requirements.
This guidance has been categorised as “leap-frog” guidance, meaning that it is intended to provide information on the FDA’s initial thinking on 3D-printed devices and how to characterise and validate such devices. Recommendations are likely to evolve as the technology develops. The final guidance also highlights that the recommendations made will not be relevant to all 3D-printed devices due to the multitude of available additive manufacturing technologies and materials.
The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers and is working to provide a more comprehensive regulatory pathway.
To help ensure the safety and effectiveness of these products, the FDA are working to establish a regulatory framework for how they “plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.”
To read the FDA 3D printing guidance, please click here.