Formlabs Healthcare Regulatory Information
Formlabs is an industry-leading manufacturer of 3D printers and materials used by healthcare providers to support the practice of medicine.
3D printed anatomical models that are marketed for diagnostic use may be considered medical devices and may be subject to regulation. As of this writing, the latest FDA Current Practices and Regulations document can be found here. We recommend that point-of-care manufacturers become familiar with the entire document, particularly slide 16.
Formlabs Form 2 is the first and only stereolithography 3D printer to be validated by Materialise as part of the the first FDA-cleared process to create accurate anatomical models for diagnostic use. While a growing number of free and commercial segmentation software is available, in some cases within the United States, models marketed for diagnostic use must be prepared using software cleared by the FDA, such as Materialise Mimics inPrint. Please consider local regulations, material data sheets, sterilization requirements, and institutional requirements before 3D printing or using anatomical models.