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Under this alternative pathway, a medical device that has received FDA marketing authorization (that is, has been approved or cleared by, or had a De Novo classification request granted by, FDA) as a Breakthrough Device, for the indication covered by the Breakthrough Device designation, will need to meet the requirements of 412.87(c)

Because this article has 5 major sections, scan the headings first and then use the FAQ or summary sections to pressure-test the answer