FDA Simplifies Fee Discounts for Small Device Innovators
Published Date: 6/9/2025
Notice
Summary
The FDA is asking for approval to collect info from small medical device businesses to see if they qualify for fee discounts. This helps small companies save money when they submit their devices for approval. If you run a small medical device business, keep an eye out for deadlines to apply and save some cash!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Small Medical Device Fee Discounts
If you run a small medical device business, the FDA will collect information to determine whether you qualify for user-fee discounts when you submit devices for approval. The collection is submitted to OMB for review under the Paperwork Reduction Act, and small businesses should watch for deadlines to apply to receive those discounts.
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.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
Previous / Next Documents
Previous: 2025-10386, Service Performance Measurement Systems for Market Dominant Products
The Postal Service wants to update how it measures delivery speed and service for its main mail products. These changes could affect customers and businesses who rely on mail, and the public is invited to share their thoughts soon. This update aims to make mail service clearer and better, with decisions coming in the near future.
Next: 2025-10388, New Postal Products
The Postal Service just filed a new deal for special mail services, and the Commission is checking it out. This affects businesses and customers who use these special mail options, with possible changes in prices or services soon. Everyone’s invited to share their thoughts before any final decisions are made!