Regulatory Information: Anatomical Models used in Preoperative Planning
Formlabs is an industry-leading manufacturer of 3D printers and materials used by healthcare providers to support the practice of medicine. Bold blue text below indicates a link to a third party webpage with supporting information. Questions? Email [email protected].
3D printed anatomical models that are marketed for diagnostic use in the US 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 anyone printing at the point-of-care become familiar with the entire document, particularly slide 16. The FDA is also leading a stakeholder engagement process, of which Formlabs is an active member, and released a public discussion paper in December 2021.
As of today, segmentation software that converts medical imaging (e.g. CT/MRI) into files required for 3D printing is considered a medical device and may be subject to regulation. Vendors of such software have received FDA 510(k) clearances with validated 3D printers and materials as part of the cleared processes. The outputs of these validated processes can be marketed for diagnostic use in the US.*
In 2018, Formlabs Form 2 was the first and only stereolithography 3D printer to be validated by Materialise as part of the the first FDA-cleared process to create accurate patient-specific anatomical models for diagnostic use. Since that time, Formlabs continues to offer the most affordable 3D printers that have been validated in 510(k)s for the production of diagnostic use anatomical models across multiple specialties. As of November 1, 2022, the list of FDA-cleared processes includes:
- Materialise Medical: Form 3B and Form 3BL have been validated by Materialise as part of its FDA 510(k) cleared process using Mimics software.
- Synopsys: Form 3B and Form 3BL have been validated by Synopsys as part of its CE and FDA 510(k) cleared process using Simpleware software. Reglatory details can be found here.
- Medviso: Form 3B+ and Fuse 1 have been validated by Medviso as part of its CE-marked and FDA 510(k) cleared process for Segment 3D Print. Additional regulatory approvals can be found here.
- Axial3D: Formlabs printers have been validated as part of the FDA 510(k) for the Axial3D Cloud Segmentation Service. Note this is a cloud-based segmentation-as-a-service model and not desktop software.
Formlabs also announced a collaboration with GE Healthcare to support radiologists who use GE Healthcare’s Advantage Workstation to prepare 3D CT or MRI data to assist in diagnosis and procedure planning, then export using 3D Suite in a form that is ready for 3D printing on Formlabs systems.
While a growing number of free, open-source and commercial segmentation software is available, in some cases and countries models marketed for diagnostic use should be prepared using segmentation software cleared by the FDA. Please consider local regulations, material data sheets, software capabilities, sterilization requirements, and institutional requirements before 3D printing or using anatomical models.
*The desktop software and services are designed for the transfer of DICOM imaging information from a medical scanner to an output file. The software and service generate an output file (e.g. STL, OBJ) that can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software and/or service and prints should be used in conjunction with other diagnostic tools and expert clinical judgement.