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Although loss of confidential health information is generally not considered to be a direct impact on safety and effectiveness, under Section 524B of the FD&C Act, a person who submits a 510(k), PMA, PDP, De Novo, or HDE for a device that meets the definition of a cyber device is required to submit information to ensure that cyber devices meet the cybersecurity requirements under section 524(b) of the FD&C Act

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Preclinical and clinical studies have demonstrated the efficacy of MenSCs in treating infertility, premature ovarian insufficiency, intrauterine adhesions, hepatic disorders, cutaneous injuries, and neurological diseases

Protective effect of black garlic extracts on tert-Butyl hydroperoxide-induced injury in hepatocytes via a c-Jun N-terminal kinase-dependent mechanism