Recognition List 066 is now formally published
FDA published Modifications to the List of Recognized Standards, Recognition List Number: 066 in the Federal Register on August 24, 2026. The notice covers additions, withdrawals and replacements, corrections, and revisions to FDA-recognized consensus standards used in premarket submissions and other device requirements.
An important timing point is that many List 066 entries were already added to FDA’s Recognized Consensus Standards Database on May 25, 2026. FDA states that manufacturers may use a recognized standard in a declaration of conformity once it is entered into the database, without waiting for the next periodic Federal Register notice.
For regulatory teams, the August notice is therefore a formal publication milestone rather than the first date on which every List 066 standard became usable.
Several high-impact standards have changed
ISO 10993-1:2025 is recognized with limitations
FDA recognizes ISO 10993-1 Sixth edition 2025-11 under Recognition No. 2-313 for biological evaluation of medical devices.
The recognition is partial. FDA’s Supplementary Information Sheet specifically notes, among other limitations, that Clause 6.9 on biological risk estimation conflicts with provisions of FDA-recognized ISO 14971:2019.
FDA will continue accepting declarations of conformity to the superseded ISO 10993-1:2018 recognition, Rec# 2-258, through July 1, 2029. After that transition period, declarations of conformity to the superseded recognition will no longer be accepted.
ISO 10993-12 and ISO 20417 enter new transition periods
ISO 10993-12:2021 including Amendment 1:2025 is completely recognized under Rec# 2-314. FDA will accept declarations of conformity to the superseded Rec# 2-289 through July 1, 2029.
FDA also completely recognizes ISO 20417 Second edition 2026-03 under Rec# 5-149 for information supplied by the manufacturer. The superseded ISO 20417 recognition, Rec# 5-135, remains acceptable for declarations of conformity through July 1, 2029.
MRI safety marking moves to ASTM F2503-26
FDA recognizes ASTM F2503-26 under Rec# 8-649 for marking medical devices and other items for safety in the magnetic resonance environment.
Declarations of conformity to the superseded ASTM F2503-23 recognition, Rec# 8-602, remain acceptable through July 2, 2028.
List 066 also adds newly recognized standards
The notice includes standards newly added to FDA’s recognized list, not only replacements of older editions.
Examples include:
- IEC 80601-2-26 First Edition 2024-03 for the basic safety and essential performance of electroencephalographs, Rec# 17-23.
- ISO 7176-31 First edition 2023-05 for lithium-ion battery systems and chargers used with powered wheelchairs, Rec# 16-241.
- IEEE Std 1752.1-2021 for representation of mobile-health metadata, sleep, and physical-activity measures, Rec# 13-158.
These entries illustrate the breadth of List 066 across biological evaluation, labeling, electrical medical equipment, mobility devices, and software/informatics.
A declaration of conformity depends on FDA’s recognition details
FDA recognition allows manufacturers, when appropriate, to submit a declaration of conformity to a recognized consensus standard to support portions of a medical-device premarket requirement. Appropriate use of recognized standards may reduce the amount of supporting testing documentation that would otherwise be submitted.
The standard designation alone is not enough.
FDA recognition may be complete or partial, and each Supplementary Information Sheet may define the extent of recognition, applicable limitations, transition periods, and related regulatory information. A standards matrix that records only the ISO, IEC, ASTM, or AAMI edition can therefore miss information that directly affects a U.S. submission.
What manufacturers can check now
- Identify U.S. submissions and technical files that still reference recognition numbers replaced under List 066.
- If a project will continue using a superseded edition for a declaration of conformity, record the applicable FDA transition deadline in the regulatory plan.
- For partially recognized standards, confirm that the declaration of conformity does not imply conformity beyond FDA’s recognized scope.
- Check products affected by biological evaluation, labeling and IFU requirements, MRI safety marking, EEG requirements, powered-wheelchair battery systems, or mobile-health data representation.
- Add FDA Recognition Number, extent of recognition, Supplementary Information Sheet link, and transition period to the internal standards database rather than tracking only the standard edition.
List 066 affects different products in different ways. A practical first step is to filter the modified standards against the standards already used by each product, then review the FDA Supplementary Information Sheet for each relevant entry before changing a submission strategy.
Sources
- Primary official sourceFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066 (opens in a new tab)Office of the Federal Register
- Supporting sourceFederal Register, August 24, 2026 — Document 2026-17229 (opens in a new tab)U.S. Government Publishing Office
- Supporting sourceRecognized Consensus Standards: ISO 10993-1 Sixth edition 2025-11 (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRecognized Consensus Standards: ISO 10993-12 Fifth edition 2021-01, including Amendment 1:2025 (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRecognized Consensus Standards: ISO 20417 Second edition 2026-03 (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRecognized Consensus Standards: ASTM F2503-26 (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceDivision of Standards and Conformity Assessment (opens in a new tab)U.S. Food and Drug Administration