FDA Updates Medical Device Standards List—List Number 066 Arrives
Published Date: 8/24/2026
Notice
Summary
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
FDA publishes Recognition List 066
The FDA published "Modifications to the List of Recognized Standards, Recognition List Number: 066," effective August 24, 2026. The notice is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Many standards withdrawn and replaced
The notice lists multiple consensus standards that FDA is withdrawing and replacing with newer versions (for example, ISO 10079-1; ISO 10993-1; ISO 10993-12; ISO 5840 series; IEC 60601-2-2; ASTM F2942-25 and others), as shown in Table 1. These modifications are incorporated under Recognition List Number: 066 and are applicable August 24, 2026.
New recognized standards added
Table 2 of the notice lists new entries added to FDA's list of recognized consensus standards (Recognition List Number: 066), including many dental ANSI/ADA standards (e.g., ANSI/ADA 113-2015, 126-2015, 135-2015), ISO 7176-31 (Lithium-ion battery systems for powered wheelchairs, edition 2023-05), IEC 80601-2-26 (electroencephalographs, edition 2024-03), and IEEE Std 1752.1-2021. These newly recognized standards are part of the modifications adopted under Recognition List Number: 066.
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