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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

If the response to an AI request does not successfully address all deficiencies, FDA will issue an order declaring a device not substantially equivalent (NSE) to a legally marketed predicate device (NSE letter). an administrative appeal) under 21 CFR 10.75

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Next-Gen Bar Exam That Truly Tests Daily Practice Skills Must Include Technology

LawTechnologyToday

In today’s legal profession, lawyers must be technologically competent. Law schools have a duty to maintain a rigorous program of legal education and enable students to develop their professional identity. Hainsworth Law Library, is well-known for his Legal Tech Institute for practicing attorneys. and Comment 8.