The Food and Drug Administration (FDA or 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: 063" (Recognition List Number: 063), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
This is a notice published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.
This document is classified as a notice. It may or may not create enforceable regulatory obligations depending on its specific content.
Notice.
Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 20, 2025.
| Document Number | 2025-04711 |
| FR Citation | 90 FR 13167 |
| Type | Notice |
| Published | Mar 20, 2025 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket No. FDA-2004-N-0451 |
| Pages | 13167–13174 (8 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
| No paired documents | ||||
| Doc # | Type | Title | Published |
|---|---|---|---|
| 2025-11792 | Notice | Food and Drug Administration Modernizati... | Jun 26, 2025 |
| 2024-13777 | Notice | Food and Drug Administration Modernizati... | Jun 24, 2024 |
| 2024-04376 | Notice | Food and Drug Administration Modernizati... | Mar 1, 2024 |
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