FDA Commissioner Scott Gottlieb, MD, has recently released a statement on how the agency has been working newly developed 3D Printed Products, with already reviewing over 100 3D printed devices on the market, including patient-specific implants and knee replacements and the first 3D printed drug. Now, they have also issued new guidance in order to advise medical device manufacturers on the technical aspects of 3D printing, along with recommendations from agency that manufacturers are to include on their 3D printed medical device submissions.

Source: https://www.fda.gov/RegulatoryInformation/Guidances/default.htm