| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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5-149
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| Standard | |
ISO 20417 Second edition 2026-03
Medical devices - Information to be supplied by the manufacturer |
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Scope/AbstractNOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over requirements of this document. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ISO 20417 First edition 2021-04 Corrected version 2021-12 [Rec# 5-135] will be superseded by recognition of ISO 20417 Second edition 2026-03 [Rec# 5-149]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-135] until July 1, 2029. After this transition period, declarations of conformity to [Rec# 5-135] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR 660 Biologics, labeling, reporting, and recordkeeping requirements |
| 21 CFR 801 Labeling, medical devices, reporting and recordkeeping requirements |
| 21 CFR 809 Labeling, in vitro diagnostic products |
| 21 CFR 820 Quality Management System Regulation |
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Relevant FDA Guidance and/or Supportive Publications*
1. 81 FR 38911 FDA Final Rule: Use of Symbols in Labeling, Issued June 2016
2. IMDRF N52 (Edition 2) Principles of Labeling for Medical Devices and IVD Medical Devices, Issued April 2024
3. IMDRF N47 (Edition 2) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, Issued April 2024
4. 78 FR 58786 FDA Final Rule: Unique Device Identification System, with a technical amendment
5. Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)- Guidance for Industry and Food and Drug Administration Staff, issued July 2021
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
