🧪FDA Classifies Menopause Test System Under Class II Regulations
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the menopause test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the menopause test system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
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The regulation classifies the menopause test system as class II, establishing special controls that companies must follow to ensure safety and effectiveness. Compliance with these requirements can influence market entry, product development, and regulatory costs, impacting financial performance for businesses involved in manufacturing or distributing medical devices.