FDA Slots Fertility Hormone Test into Safety Sweet Spot
Published Date: 5/30/2025
Rule
Summary
The FDA is officially putting the anti-mullerian hormone test system into a special safety category called Class II. This means the test will have clear rules to keep it safe and effective, helping patients get better access to this important health tool. Labs and device makers should get ready for these changes, which aim to make things smoother without extra costs or delays.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
AMH Test Reclassified to Class II
The FDA is classifying the anti‑mullerian hormone (AMH) test system as Class II (special controls). This classification is intended to provide a reasonable assurance of the device's safety and effectiveness under those special controls.
FDA Says Access to AMH Tests Will Improve
The FDA states that classifying the AMH test system as Class II will enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. This is meant to make it easier for patients to obtain AMH testing and related innovations.
Labs and Device Makers Should Prepare
The rule signals that laboratories and medical device manufacturers of AMH test systems should get ready for the new Class II (special controls) requirements. The FDA says the classification aims to reduce regulatory burdens and make the process smoother, and the agency indicates these changes should not add extra costs or delays.
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