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Start Over Subjects Device Approval -- legislation & jurisprudence ✖Remove constraint Subjects: Device Approval -- legislation & jurisprudence Subjects Device Approval -- standards ✖Remove constraint Subjects: Device Approval -- standards Titles 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff ✖Remove constraint Titles: 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

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