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

MANUFACTURING INERT GAS FLOW PATH STRATEGIES FOR MULTI-LASER POWDER BED FUSION SYSTEMS AND THEIR IMPACT ON LATTICE STRUCTURE MECHANICAL RESPONSES * Sean P. Philips * , Abigail Tetteh *  … 

Daniel A. Porter _3D Printing in Medicine_ Open Access 08 April 2024 ACCESS OPTIONS Access through your institution Subscribe to this journal Receive 12 digital issues and online access to

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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._

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(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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