The US Food and Drug Administration (FDA) have issued draft guidance for 3D printed medical devices
The guidance document is being distributed for comment purposes only and states that it was developed “to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing” and to outline “recommendations for testing and characterisation for devices that include at least one [Additive Manufacturing] fabrication step.”
The document addresses: design and manufacturing considerations as well as device testing considerations including characterisation, validation and verification.
According to the Regulatory Affairs Professionals Society (RAPS), the “FDA says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues, and cautions that ‘point-of-care device manufacturing may raise additional technical considerations’ not covered in the draft guidance.”
According to the FDA, the public has until early August to provide comments on the draft guidance.