On December 12, 2019, the U.S. Food & Drug Administration (FDA) published this letter to Outset regarding their Tablo® Hemodialysis System. In the letter, the FDA grants Outset approval to market the device in the U.S. as a substantial equivalence in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). The FDA subsequently approved Outset’s Tablo Hemodialysis System for home use on March 31, 2020 . . .
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