Not sure how this varies from existing minimal risk waivers for irb, which go back to 1990s. Maybe just expanding them to fda domain where they were oddly missing till now
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https://www.jdsupra.com/legalnews/fda-issues-final-rule-permitting-irb-9116244/
https://www.govinfo.gov/content/pkg/FR-2017-07-25/pdf/2017-15539.pdf
https://www.fdanews.com/ext/resources/files/2017/07/07-24-17-IRB-Waiver.pdf?1519353957
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