Sources of evidence included the submitted De Novo request document and the corresponding FDA De Novo classification decisions (FDA Evaluation of Automatic Class III Designation De Novo Summaries), as well as the principal US federal laws (1938-2023) and the FDA regulations and guidance (19762023) relating to medical devices, including the (1) Food, Drug, and Cosmetic Act of 1938, (2) Radiation Control for Health an Safety Act of 1968, (3) Medical Device Amendments of 1976, (4) Safe Medical Devices Act of 1990, (5) FDA Modernization Act of 1997, (6) Medical Device User Fee and Modernization Act of 2002, (7) FDA Amendments Act of 2007, (8) FDA Safety and Innovation Act of 2012, (9) 21st Century Cures Act of 2016, and (10) FDA Reauthorization Act of 2017
Warning signs include decreased urine output despite increased frequency attempts, dark urine, dizziness, rapid heartbeat, or confusion
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While it isnt a therapy for hormonal symptoms themselves, it can be a valuable aid for addressing weight-related challenges that often accompany menopause
