FDA releases new guidance on 3D printed medical products

The industry witnessed a world-first last week, as the US Food and Drug Administration  released guidance for manufacturers 3D printing medical products

This year’s news of the first 3D printed drug receiving FDA approval illustrated the surprising speed of life-changing technologies in today’s market.

The FDA is working to keep pace with these advances and provide a ‘comprehensive regulatory pathway’ to facilitate access to safe and effective innovations.

FDA guidance

The document signals the FDA’s positioning and initial thoughts on the technology.  However, the views are likely to evolve as it builds a regulatory framework incorporating 3D printed personalised devices for patients.

Industry response

Many in the industry applauded the FDA for its forward thinking, commitment and appreciation for the technology, noting that the guidance does indeed provide a clearer path for the industry.

FDA methodology

The body reviewed over 100 devices produced by 3D printers. These products are custom tailored to a patient’s requirements such as implants to fit unique openings in skull or facial reconstructions.

The authority also envisions that one day entire replacement organs will be 3D printed and burn patients will have their new skin cells 3D printed directly onto burn wounds.

The guidance covers a range of areas including: patient-matched device design, software workflow, biocompatibility and mechanical testing.

View the guidance in full here: Technical Considerations for Additive Manufactured Medical Devices