| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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13-79
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| Standard | |
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
Medical device software - Software life cycle processes |
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Identical AdoptionANSI AAMI IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
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Scope/Abstract| IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). |
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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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Relevant FDA Guidance and/or Supportive Publications*
1. Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
2. Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
5. General Principles of Software Validation - Guidance for Industry and FDA Staff, issued January 2002
6. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
7. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.
8. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
9. Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration, issued July 2020.
10. Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
11. Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff, issued January 2026.
12. 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. |
