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

subscribe This is a preview of subscription content, access via your institution RELEVANT ARTICLES Open Access articles citing this article. * A REVIEW OF ADDITIVE MANUFACTURING IN TISSUE

ENGINEERING AND REGENERATIVE MEDICINE * Clayton J. Culbreath * , M. Scott Taylor *  … O. Thompson Mefford _Biomedical Materials & Devices_ Open Access 20 June 2024 * ADDITIVE

articles $119.00 per year only $9.92 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local 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 medical

devices. _Addit. Manuf._ 6, 517–553 (2021). Article  Google Scholar  * Ricles, L. M., Coburn, J. C., Di Prima, M. & Oh, S. S. Regulating 3D-printed medical products. _Sci. Transl. Med._

10, eaan6521 (2018). Article  Google Scholar  * Wohlers, T., Campbell, I., Diegel, O. & Kowen, J. _Wohlers Report 2022_ https://wohlersassociates.com/product/wohlers-report-2022/

(Wohlers Associates, 2022). * McCarthy, M. C. et al. Trust in the time of Covid-19: 3D printing and additive manufacturing (3DP/AM) 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 Technologies–General Principles–Terminology_ 1–9 (ASTM

International, 2015). * Rafi, K., Zhonghong Liu, A., Di Prima, M., Bates, P. & Seifi, M. Regulatory and standards development in 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

* Issue Date: October 2023 * DOI: https://doi.org/10.1038/s44222-023-00109-6 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable

link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative