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Zika Virus Emergency Use Authorization. On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS), Sylvia ...

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Jun 28, 2021·510 (k) Premarket Notification. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval.

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