FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions.
“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we 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,” FDA Commissioner Scott Gottlieb said in a statement.
Gottlieb also highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing. FDA is describing the document as a “leapfrog guidance” because it offers initial thoughts on technologies emerging in the industry.