FDA blesses room-temp goo for storing your blood vessels?
Published Date: 9/30/2026
Rule
Summary
The FDA is officially putting the flushing and storage solution for vascular autografts at room temperature into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps companies bring these devices to patients faster and safer, starting from September 30, 2026, with the classification effective since October 4, 2023. Medical device makers and patients will benefit from easier access to these important solutions without extra costs or delays.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Patients gain faster access to device
The FDA classified the flushing and storage solution for vascular autografts at room temperature into Class II with special controls, a change FDA says will enhance patients' access to beneficial innovation by reducing regulatory burdens. The final order is effective September 30, 2026, and the classification was applicable on October 4, 2023.
Easier regulatory path for device makers
FDA's De Novo classification lets this device be Class II and serve as a predicate for future devices, allowing other sponsors to use the 510(k) pathway instead of premarket approval. The classification was made applicable on October 4, 2023 and the order is effective September 30, 2026.
New testing and labeling requirements for makers
Manufacturers must meet the special controls: clinical data evaluating adverse events (for coronary artery bypass graft indications this must include incidence of major adverse cardiac events, vein graft occlusion, and mortality); non-clinical performance testing (including maintenance of cell viability and structural integrity during storage and evaluation of visible and non-visible particulates); shelf life testing; biocompatibility; sterility validation; and specific labeling items (maximum storage duration, additives, visual inspection for particulates, stability after preparation, and summaries of nonclinical and clinical data).
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.
2025-01840, 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.
2026-19968, Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that ISTURISA (osilodrostat) 10 mg tablets were not taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions of ISTURISA, as long as they meet all the rules. Patients and pharmacies could see more affordable options soon, with no safety worries involved.
2026-19850, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
The FDA is asking for public feedback on how it collects info about food and color additives, including their labels and safety petitions. This affects companies that want to add or change ingredients in food and how they submit their paperwork electronically. Comments are due by October 29, 2026, and the process helps keep food safe without adding extra costs or delays.
Previous / Next Documents
Previous: 2026-20067, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction
This correction fixes some technical mistakes in the FY 2027 hospice payment and wage index rules that were first published in August 2026. It mainly affects hospice providers by updating how their payments are calculated, making sure the numbers are accurate starting October 1, 2026. These changes help ensure hospices get the right payment amounts based on the latest hospital wage data.
Next: 2026-20093, Gold Star Mother's and Family's Day, 2026
Gold Star Mother's and Family's Day 2026 honors the families who lost loved ones serving in the military. The President highlights their courage and announces ongoing support, including a new Military Spouse Commission to help military families face challenges. This day reminds us all to appreciate and support these heroes’ families with respect and care.