FDA and Additive Manufacturing for Medical Devices

Is your team thinking of using additive manufacturing for a medical device?  Additive manufacturing, or 3D printing, has become a reality in many industries including orthopedics.  Several devices that leverage this technology are now on the market.  They were the first to pave the way and navigate the FDA clearance process.  The FDA has been researching and following the developments in additive manufacturing and now they’ve released draft guidance which covers many relevant topics including manufacturing and processing, cleaning and sterilization, testing, and more. This document titled “Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff” is available to the public at the link below.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

If your team needs assistance with a medical device project involving additive manufacturing, don’t hesitate to contact Engineering & Quality Solutions, Inc.   We have experience with 3D printing applications for orthopedic devices and can help you understand the unique requirements of using this technology.