On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Technical Considerations for Additive Manufactured (AM) Devices to advise manufacturers who are producing 3D-printed devices. The purpose of this draft guidance, which was published in the Federal Register, is for the FDA to obtain public feedback. The draft guidance is not final or in effect at this time, nor does it comprehensively address all considerations or regulatory requirements to establish a quality system for device manufacturing. Rather, it is a way the FDA can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development; the FDA’s recommendations may change as more information becomes available.
A boy uses his e-NABLE 3D-printed hand to ride his bike. Photograph courtesy of e-NABLE and Jen Martin Studios.
The draft guidance provides manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D-printed devices. The type of premarket submission required for a device is still determined by its regulatory classification. The FDA also said it is currently evaluating submissions for new 3D-printed medical devices to determine safety and effectiveness.
This draft guidance is broadly organized into two topic areas: Design and Manufacturing Considerations and Device Testing Considerations. The Design and Manufacturing Considerations section of the guidance provides technical considerations that should be addressed as part of fulfilling quality system requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable. The Device Testing Considerations section describes the type of information that should be provided in 510(k) premarket notification submissions, premarket approval applications, humanitarian device exemption applications, de novo requests, and investigational device exemption applications for an AM device.
For questions regarding this document, contact the Division of Applied Mechanics at 301.796.2501, the Division of Orthopedic Devices at 301.796.5650, or Matthew Di Prima, PhD, at 301.796.2507 or by sending an e-mail to matthew.diprima@fda.hhs.gov. For questions about this document regarding Center for Biologics Evaluation and Research (CBER)-regulated devices, contact the Office of Communication, Outreach, and Development at 800.835.4709 or 240.402.8010.
To submit electronic comments and suggestions regarding this draft document, visit www.regulations.gov. Written comments can be sent to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852. Identify all comments with docket number FDA-2016-D-1210. The deadline to submit comments is within 90 days of May 10.
