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  • shavondraleak replied to the topic "Discussion Topic: The de Novo 510(k) Process"3 years, 2 months ago

    The streamlining of processes is cost-effective in most cases as far as consistency and conformity across the board.  “On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.3 This final rule will add new regulations…   Read more»