The US Food and Drug Administration’s internal database of 510(k)-cleared medical devices was searched for additively manufactured devices cleared between 2010 and 2020. The information and analysis provided will assist the medical device community to further understand the application of additive manufacturing to regulated devices.
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Nature Reviews Bioengineering thanks Chee Kai Chua and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.
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510(k) pathway: https://www.fda.gov/media/82395/download
ASME Year in Review: https://resources.asme.org/ammedical-report
Discussion Paper: https://www.fda.gov/media/154729/download
Exploring its use: https://www.sme.org/smemedia/white-papers-and-reports/3d-printing-fuels-the-rise-of-point-of-care-manufacturing/
Insurance companies and hospitals: https://medium.com/@axial3D/preparing-for-the-new-medical-3d-printing-cpt-codes-part-1-5dec22e1984a
medical shortages during the pandemic: https://www.fda.gov/media/150614/download
Technical Guidance: https://www.fda.gov/media/97633/download
Three public workshops: http://wayback.archive-it.org/7993/20170111083117 / http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm; https://wayback.archive-it.org/7993/20201222130156 / https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/fdacdrh-rsna-sig-joint-meeting-3d-printed-patient-specific-anatomic-models-august-31-2017; https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-3d-printing-hospitals-veterans-health-administrations-experiences-point-care
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Fogarasi, M., Snodderly, K.L. & Di Prima, M.A. A survey of additive manufacturing trends for FDA-cleared medical devices. Nat Rev Bioeng 1, 687–689 (2023). https://doi.org/10.1038/s44222-023-00109-6
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DOI: https://doi.org/10.1038/s44222-023-00109-6
