FDA's Tedious Typo Cleanup in Device Quality Rules
Published Date: 12/4/2025
Rule
Summary
The FDA is updating some medical device rules to fix typos, clear up confusing language, and make sure everything matches their recent Quality Management System changes. These updates don’t add new requirements or costs but help keep the rules neat and easy to follow. The changes take effect on February 2, 2026, and affect anyone involved with medical device regulations.
No Economic Impacts Identified for this Document
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: 2025-21943, Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota Transfer From Rhode Island to North Carolina
Rhode Island is sharing 50,000 pounds of its 2025 commercial bluefish quota with North Carolina to help balance fishing opportunities this year. This change affects fishermen in both states and runs from December 3 to December 31, 2025. It ensures the total bluefish catch stays on track while helping North Carolina meet its fishing goals.
Next: 2025-21960, Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfer From North Carolina to Massachusetts
North Carolina is sharing some of its 2025 summer flounder fishing quota with Massachusetts to help both states meet their fishing goals. This change kicks in on December 3, 2025, and lasts through the end of the year. Fishermen in both states should get ready for the updated limits, which aim to keep the fishery healthy and fair.