On December 5, 2017, FDA-CDRH issued a final guidance document on additive manufacturing replacing the May 10, 2016 draft version.
The final guidance document, Technical Considerations for Additive Manufactured Devices (UCM499809) outlines technical considerations associated with additive manufacturing processes, and recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step.
The final guidance document includes 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.
- 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 additive manufacturing device.