Source: MPMN Medtec Pulse
The FDA has released “leapfrog” draft guidance for the rapidly evolving world of 3-D printed medical devices.
The agency based the guidance on input from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. The document covers device design, manufacturing, and design testing. For the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.
Manufacturers would have to clearly identify every step in the 3-D printing process, and might need to submit a “high-level summary of each critical manufacturing process step,” the guidance says. They would also have to document each step’s risk, and describe how they would mitigate those risks.
Read More: FDA has Important New Views on 3-D Printed Devices
