FDAFinal Rule
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
Healthcare
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Summary
The FDA is officially classifying menopause test systems as medical devices and establishing safety and effectiveness standards for them. This means manufacturers of at-home menopause tests will need to follow specific FDA rules to ensure their products are reliable and safe for consumers.
Key Points
- 1Menopause test systems (devices that measure hormone levels to detect menopause) are now formally regulated as medical devices by the FDA
- 2Manufacturers must follow FDA requirements for safety, accuracy, and proper labeling before selling these tests to the public
- 3This classification helps protect consumers by ensuring menopause tests have been evaluated and proven to work as advertised
- 4The regulation applies to companies that make or sell at-home menopause testing kits and similar diagnostic devices
- 5Healthcare providers and patients can have more confidence in the reliability of menopause test results due to FDA oversight
Key Dates
Published
August 21, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
The Digest Network
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