FDA Updates Standards List for Device Makers
Published Date: 2/19/2026
Notice
Summary
The FDA just updated its official list of standards that medical device makers can use to prove their products are safe and effective. These changes, effective February 19, 2026, help companies speed up the approval process by following clear, recognized rules. If you’re in the medical device world, this means smoother reviews and no surprise costs or delays!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Updated recognized standards list
The FDA published modifications to its list of recognized consensus standards that are applicable February 19, 2026. You are a medical device manufacturer if you elect to declare conformity with these standards to meet parts of premarket review submissions, and the FDA says the publication will assist those manufacturers in meeting certain device requirements.
Many standards withdrawn and replaced
The notice lists specific recognized consensus standards that the FDA is withdrawing, correcting, revising, or replacing with newer versions (for example, many ISO and ASTM standards across anesthesiology, biocompatibility, cardiovascular, dental, orthopedics, materials, and other device areas). These changes are incorporated under "Recognition List Number: 065" and are applicable February 19, 2026.
Searchable database and ongoing updates
FDA is incorporating these Recognition List Number: 065 modifications into its searchable database (accessible via FDA websites) and states it will announce additional modifications once a year or more often if needed. You can use the searchable database to find the current FDA-recognized consensus standards.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2026-03309 — Indian Energy Service Center; Receipt of Tribal Energy Resource Agreement for the Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado
The Southern Ute Indian Tribe in Colorado has submitted a Tribal Energy Resource Agreement (TERA) that lets them manage energy projects on their land without needing extra government approval. The Department of the Interior is reviewing this agreement and wants public comments by March 23, 2026. If approved, this will speed up energy deals and give the Tribe more control over their resources.
Next: 2026-03311 — Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA wants your thoughts on how they collect info about safely processing and importing fish and seafood. This affects businesses that handle fish products, aiming to keep seafood safe and clean. You’ve got until April 20, 2026, to share your comments—no fees, just your voice helping shape safer seafood rules!
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in