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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20663, Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
The FDA wants your thoughts on how they collect info about food products that might have tiny amounts of banned or changed pesticides. This affects farmers, food sellers, and anyone handling these foods, making sure safety rules keep up with new pesticide limits. You’ve got until December 7, 2026, to share your views—no cost, just your voice!
Previous / Next Documents
Previous: 2025-09769, Airworthiness Directives; Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Airplanes
If you own or work with Airbus Canada BD-500-1A11 airplanes, listen up! The FAA updated safety rules to fix a mistake in the old repair list and still wants you to check and fix any damage or repairs on your planes. These changes keep everyone flying safe and don’t add new costs, but you gotta act on time!
Next: 2025-09777, Special Local Regulations; Marine Events Within the Fifth Coast Guard District-Cape May, NJ
On June 22, 2025, the Coast Guard will set special rules for the Around the Island Paddle event near Cape May, NJ to keep everyone safe on the water. Boat operators in the area must follow instructions from Coast Guard patrols, and anyone not part of the event needs permission to enter. This means some waterway access will be limited for a short time, but it’s all about making sure the event goes smoothly and safely.