The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.
The FDA defines additive manufacturing as “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.”
The draft guidance, which was released in May 2016, outlines technical considerations for 3D printing processes and recommendations for testing and characterization for devices that are made with 3D printing methods. It is considered a “leap-frog guidance” that is intended as a way for the FDA to share initial thoughts regarding an emerging technology, although the Agency’s recommendations may change when more information becomes available.
The guidance takes into consideration an FDA-sponsored workshop from October 2014 where experts and industry stakeholders discussed the benefits and challenges of additive manufacturing. At the meeting, medical device manufacturers, additive manufacturing companies, and academics discussed technical considerations for 3D printed medical devices. The FDA has already approved the first 3D printed drug in March 2016: a dissolvable epilepsy medication called SPRITAM.
Read the draft guidance on additive manufacturing for medical devices at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf.
Submit comments at: https://www.regulations.gov.