Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Published Date: 2/6/2026
Notice
Summary
The FDA is thinking about letting some medium-risk medical devices skip a step called premarket notification, which means faster and easier approval. They want to hear from the public by April 7, 2026, before making a final decision. This could save time and money for device makers and get helpful devices to patients quicker.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Listed Class II Devices May Be Exempt
FDA proposes that the class II device types listed in Table 1 and Table 2 would no longer require premarket notification under section 510(k) if the proposal is finalized. FDA says this final action "will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures" because manufacturers "will no longer have to invest time and resources in 510(k) submissions" for exempt devices.
Exemptions Limited; Some Devices Still Need 510(k)
FDA proposes partial limitations so that only devices meeting specified conditions would be exempt; devices that fall outside those partial limitations would remain subject to 510(k). For example, a uterine tenaculum would be exempt only if it is a manual mechanical device, and powered uterine tenacula (such as vacuum-based devices) would still require premarket notification.
New Product Codes for Exempt Devices
If exemptions are finalized, FDA will assign new product codes to device types that become exempt so they can be identified separately from devices that remain subject to 510(k). Exempt and non-exempt devices within the same device type will therefore have different product codes.
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.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
Previous / Next Documents
Previous: 2026-02376, Foreign-Trade Zone (FTZ) 110, Notification of Proposed Production Activity; Intel Foundry Corporation; (Semiconductor Products); Rio Rancho and Albuquerque, New Mexico
Intel Foundry Corporation wants to start making advanced semiconductor products at its Rio Rancho and Albuquerque, New Mexico sites under special Foreign-Trade Zone rules. This move lets them use certain imported materials duty-free, helping save money and speed up production. The government is reviewing this plan, which could boost local tech manufacturing soon.
Next: 2026-02378, Indian Gaming; Approval by Operation of Law of the First Amendment to the Tribal-State Gaming Compact Between the State of California and the Sycuan Band of the Kumeyaay Nation
The first amendment to the gaming agreement between California and the Sycuan Band of the Kumeyaay Nation is now officially approved by law as of February 6, 2026. This means the tribe can continue running certain casino games under updated rules without delay. No extra money changes were announced, but the approval keeps the gaming partnership strong and on track.