FDA has developed this draft guidance to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad 3D-Printercategory of manufacturing encompassing 3-dimensional (3D) printing. Additive manufacturing (AM) is 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. Rapid technological advancements and increased availability of AM fabrication equipment are encouraging increased investment in the technology and its increased use in medical devices. 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 AM fabrication step.

This draft guidance is broadly organized into two topic areas; Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI).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 or regulation to which your device is subject, if applicable. While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality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

Considerations 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.

Point-of-care device manufacturing may raise additional technical considerations. The recommendations in this guidance should supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.

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, all AM questions pertaining to products containing biologics, cells or tissues should be directed to the Center for Biologics Evaluation and Research (CBER).

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