FDA has issued draft guidance for 3D printed medical devices which includes recommendations for testing and characterisation. However, Regulatory Affairs Professionals Society (RAPS) added- “FDA says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues" but FDA waits for public comments.

Source: http://www.medicalplasticsnews.com/news/3d-printed-medical-devices-given-fda-draft-guidance/

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