On May 10, 2016, FDA-CDRH issued a draft guidance on additive manufacturing, Technical Considerations for Additive Manufactured Devices (UCM499809). This is a leap-frog guidance, intended to share initial thoughts regarding emerging technologies likely to be of public health importance.
The draft guidance includes two topic areas: Design and Manufacturing Considerations and Device Testing Considerations. The Design and Manufacturing Considerations section provides technical considerations in fulfilling Quality System (QS) requirements for the device. The Device Testing Considerations section describes the information to provide for premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests, and investigational device exemption (IDE) applications.