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. 2023 Jan 16;2:e42940. doi: 10.2196/42940

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©Meghavi Mashar, Shreya Chawla, Fangyue Chen, Baker Lubwama, Kyle Patel, Mihir A Kelshiker, Patrik Bachtiger, Nicholas S Peters. Originally published in JMIR AI (https://ai.jmir.org), 16.01.2023.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR AI, is properly cited. The complete bibliographic information, a link to the original publication on https://www.ai.jmir.org/, as well as this copyright and license information must be included.

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The current Food and Drug Administration (FDA) regulatory pathway. *A predicate: if the algorithm is found to be substantially equivalent to a legally marketed device. **A preamendment device: devices legally marketed in the United States before May 28, 1976, which have not been significantly changed/modified and for which no regulation requiring premarket approval has been published by the FDA.