FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions
FDA Law Blog
NOVEMBER 22, 2021
Like the 2005 guidance, this new draft guidance applies to all types of premarket submissions, but now the Agency has specifically added De Novo Classification Requests and Biologics License Applications (BLA). To put the age of the existing guidance into perspective, it was published two years before the first iPhone was released.
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