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. 2022 Apr 20;6:38. doi: 10.1186/s41687-022-00444-z

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© The Author(s) 2022

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — PRO inclusion in summary documents fiscal year 2015- fiscal year 2020. The 510(k) cohort consisted of cleared 510(k)s that included clinical trial data. The majority of De Novos granted in fiscal year 2020 did not have summary documents posted within the study window leading to the low n observed. There were no HDE approvals publicly posted in fiscal year 2020. FY = Fiscal year