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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 13-79
Standard
IEC  62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
Medical device software - Software life cycle processes
Identical Adoption
ANSI AAMI IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
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).
Extent of Recognition
Complete standard
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.
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Issued May 11, 2005.

2. Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Issued September 9, 1999.

3. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Issued January 11, 2002.

4. Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software, Issued January 14, 2005.

5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, Issued October 2, 2014.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Lisa Simone
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2591
  Lisa.Simone@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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