FDA has developed this guidance to provide the Agency’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. Additive manufacturing (AM) is a process that builds an object by sequentially building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative designs without the need for retooling and to create complex devices built as a single piece. Rapid technological advancements and increased availability of AM fabrication equipment are encouraging increased investment in the technology and its increased use by the medical device industry. The purpose of this guidance is to outline technical considerations associated with AM processes, and recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step.

 

This guidance is broadly organized into two topic areas: Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI). The Design and Manufacturing Considerations section provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for your device, as determined by the regulatory classification of your device and/or regulation to which your device is subject, if applicable. While this guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of your device. The Device Testing Consideration section describes the type of information that should be provided in premarket notification submissions (510(k)), premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo requests and investigational device exemption (IDE) applications for an AM device. The type of premarket submission that is required for your AM device is determined by the regulatory classification of your device. Questions regarding the regulatory status or requirements for specific devices, products, or entities should be addressed to the appropriate review branches through the Division for Industry and Consumer Education (DICE@fda.hhs.gov).

For devices manufactured using AM, the recommendations in this guidance supplement any device-specific recommendations outlined in existing guidance documents or applicable  FDA-recognized consensus standards. Point-of-care device manufacturing may raise additional technical considerations that are not addressed in this document. In addition, this guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM. Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Therefore, AM questions pertaining to biologics, cells or tissue products should be directed to the Center for Biologics Evaluation and Research (CBER). Specific questions regarding jurisdiction over a combination product should be
directed to the Office of Combination Products (OCP) at 301-427-1934 or combination@fda.gov.

This guidance is a leapfrog guidance, a type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leapfrog guidance represents the Agency’s initial thinking and our recommendations may change as more information becomes available. The Agency encourages manufacturers to engage with the Center for Devices and Radiological Health (CDRH) or CBER through the Pre-Submission process to obtain more detailed feedback for Additively Manufactured medical devices. For more information on Pre-Submissions, please see “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff – Guidance for Industry and  Food and Drug Administration Staff.”

For the current edition of the FDA-recognized standards referenced in this document, see the FDA-Recognized Consensus Standards Database Website.

Posted on the FDA website on 5 December 2017