A survey of additive manufacturing trends for fda-cleared medical devices

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. Access through your institution Buy or

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taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Salmi, M.

Additive manufacturing processes in medical applications. _Materials_ 14, 191 (2021). Article  Google Scholar  * da Silva, L. R. R. et al. A comprehensive review on additive manufacturing of

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as a solution to supply chain gaps. _NEJM Catalyst_ https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0321 (2021). * ISO/ASTM-52900. _Standard Terminology for Additive Manufacturing

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medical additive manufacturing. _MRS Bull._ 47, 98–105 (2022). Article  Google Scholar  Download references AUTHOR INFORMATION Author notes * These authors contributed equally: Magdalene

Fogarasi, Kirstie L. Snodderly. AUTHORS AND AFFILIATIONS * Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food

and Drug Administration, Silver Spring, MD, USA Magdalene Fogarasi, Kirstie L. Snodderly & Matthew A. Di Prima Authors * Magdalene Fogarasi View author publications You can also search

for this author inPubMed Google Scholar * Kirstie L. Snodderly View author publications You can also search for this author inPubMed Google Scholar * Matthew A. Di Prima View author

publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Matthew A. Di Prima. ETHICS DECLARATIONS COMPETING INTERESTS The authors

declare no competing interests. PEER REVIEW PEER REVIEW INFORMATION _Nature Reviews Bioengineering_ thanks Chee Kai Chua and the other, anonymous, reviewer(s) for their contribution to the

peer review of this work. ADDITIONAL INFORMATION RELATED LINKS 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

REGULATED: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=872&showFR=1&subpartNode=21:8.0.1.1.23.4 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 SUPPLEMENTARY

INFORMATION SUPPLEMENTARY INFORMATION RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE 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 Download citation * Published: 11 September 2023

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