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FDA’s 510(k) Guidance Emphasizes Software-as-Device Factor

New guidance is more specific about acceptance criteria for software

Russ King
Thu, 09/24/2015 - 12:15
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The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and it just released its new acceptance policy. This new standard, which will be effective Oct. 1, 2015, replaces the old FDA Refuse to Accept Policy for 510(k) Guidance of 2012.

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