FDA, VA, and NIH Address the Production and Use of 3D Printed Swabs for COVID-19

June 4, 2020
On May 15, 2020, the FDA, Department of Veterans Affairs’ Innovation Ecosystem, and the National Institutes of Health’s (NIH’s) 3D Print Exchange held a town hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 Public Health Emergency (https://www.fda.gov/medical-devices/news-events-medical-devices/virtual-town-hall-3d-printed-swabs-05152020-05152020#event-information). Key concerns included breakage of brittle 3D printed swabs, embrittlement during sterilization, the effectiveness of 3D printed swabs in capturing sufficient sample from the appropriate anatomic site without injury, compatibility with downstream assays, and appropriate labeling. Further details regarding these key considerations have been published on the NIH 3D Print Exchange website. Developers were also directed to the FDA guidance document “Technical Considerations for Additive Manufactured Medical Devices” for further information specifically about material controls, post processing, and overall process validation.

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