FDA Tweaks Device Standards List for Smoother Approvals
Published Date: 6/26/2025
Notice
Summary
The FDA just updated its list of official standards that medical device makers can use to speed up approval. This helps companies know exactly what rules to follow when getting their devices ready for sale, saving time and possibly money. These changes kick in right away, making it easier for everyone to stay on the same page.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Updates Recognized Device Standards
If you make medical devices, the FDA updated its list of recognized consensus standards in "Recognition List Number: 064." The update is meant to help manufacturers who elect to declare conformity with those standards meet certain premarket requirements, which can speed premarket review and may save time and money; the changes take effect right away.
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: 2025-11790, Information Collection: NRC Form 531, Request for Taxpayer Identification Number
The NRC is renewing its form that asks for your Taxpayer Identification Number to keep things running smoothly. If you deal with the NRC, you might need to fill out this form again soon. No big changes or costs, just a fresh approval to keep the info collection going.
Next: 2025-11795, Guidance on DOT Referrals for Potential Criminal Enforcement
The Department of Transportation (DOT) is stepping up to handle serious rule-breaking that could lead to criminal charges, following a new executive order aimed at cutting down on over-the-top punishments. This means folks and companies dealing with DOT rules should watch out for clearer, fairer enforcement starting now. It’s all about making sure penalties fit the crime without going overboard or wasting money.