FDA Classifies Menopause Test System as Class II
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.
Compliance Requirements
- #1
A menopause test system must comply with the following special controls: (1) Design verification and validation must include the following: (i) An appropriate traceability plan to minimize the risk of drift in the menopause test system results over time. (ii) Detailed documentation of a clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (A) Results must demonstrate appropriate clinical performance relative to a well-accepted and appropriate comparator. (B) Data must demonstrate accuracy of device output for each indicated specimen type throughout the device measuring range as appropriate for the intended use population.; The labeling required under § 809.10 of this chapter must include the following: (i) A statement in the indications for use that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (ii) A limiting statement that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (iii) A limiting statement appropriately describing the risks of false test results and that test results should not be relied upon in clinical decision making (e.g., to discontinue contraceptive use and/or to evaluate patients for the presence of endometrial cancer) without other clinical and laboratory findings.; This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.; For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order.; The device must comply with collections of information in part 860, subpart D, regarding De Novo classification (OMB control number 0910-0844); The device must comply with collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval (OMB control number 0910-0231); The device must comply with collections of information in part 807, subpart E, regarding premarket notification submissions (OMB control number 0910-0120); The device must comply with collections of information in 21 CFR part 820 regarding quality system regulation (OMB control number 0910-0073); The device must comply with collections of information in 21 CFR parts 801 and 809 regarding labeling (OMB control number 0910-0485)
Market Impacts
Reclassification from class III to class II with special controls reduces regulatory burden and enables market access through 510(k) pathway instead of premarket approval, enhancing patient access to beneficial innovation; Device can serve as predicate for future substantially equivalent devices under section 513(f)(2)(B)(i) of FD&C Act, enabling other sponsors to use less burdensome 510(k) process; All menopause test systems must comply with specific special controls including design verification/validation requirements and specific labeling mandates to avoid automatic class III classification; Mandatory compliance with special controls including traceability plans, clinical performance documentation, and specific labeling requirements under §809.10
Validated Company Impacts
BIO-RAD LABORATORIES, INC.
Bio-Rad's Clinical Diagnostics segment designs, manufactures, and markets test systems and test kits for clinical laboratories, which directly aligns with the menopause test system classification requirements. The company's focus on clinical diagnostics and quality controls demonstrates operational alignment with FDA medical device regulations for in vitro diagnostic devices. The FDA rule focuses entirely on medical device regulatory compliance, clinical validation, and labeling requirements for menopause test systems, with no cybersecurity or information technology components. The company's disclosed risk factors exclusively address technology cybersecurity risks (information system breaches and IT system disruptions), which have no alignment with this medical device classification rule's requirements or impacts.
Edwards Lifesciences Corp
Edwards Lifesciences focuses on cardiovascular medical devices such as heart valves and monitoring systems, not menopause test systems or clinical chemistry/toxicology devices. While the company operates in the broader medical device sector and complies with FDA regulations, its specific product portfolio shows no overlap with the menopause test systems targeted by this rule. The rule's focus on regulatory approvals, clinical performance documentation, and manufacturing quality controls directly aligns with the company's identified risks in regulatory approvals, clinical trials, and manufacturing quality problems. The special controls for design verification, validation, and labeling requirements specifically address the company's operational and regulatory compliance risk categories.
MERIT MEDICAL SYSTEMS INC
Merit Medical Systems primarily manufactures interventional medical devices such as catheters, guidewires, and embolization products, with no evidence of involvement in menopause test systems or in vitro diagnostic devices. The company's business operations focus on cardiovascular, radiology, and endoscopy procedures rather than clinical chemistry or toxicology testing devices targeted by this FDA rule. The rule directly addresses the company's FDA regulatory clearance risk by establishing a clear classification pathway for menopause test systems, which could reduce delays and costs associated with product commercialization. The special controls and labeling requirements specifically mitigate regulatory compliance risks that the company has already identified as significant concerns.