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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-97
IEC  82304-1 Edition 1.0 2016-10
Health software - Part 1: General requirements for product safety
1.1 Purpose
This Part of 82304 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.

1.2 Field of application
This document covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
In each referenced standard, the term "medical device" or "medical device software" is to be substituted by the term "health software" or "health software product", as appropriate.
Where the term "patient" is used, either in this document or in a referenced standard, it refers to the person for whose health benefit the health software is used.
IEC 82304-1 does not apply to health software which is intended to become part of a specific hardware designed for health use. Specifically, IEC 82304-1 does not apply to:
a) medical electrical equipment or systems covered by the IEC 60601/IEC 80601 series;
b) in vitro diagnostic equipment covered by the IEC 61010 series; or
c) implantable devices covered by the ISO 14708 series.
NOTE This document also applies to health software products (e.g. medical apps, health apps) intended to be used in combination with mobile computing platforms.

1.3 Compliance
Compliance with this document is determined by inspection of all documentation required by this document.
Assessment of compliance is carried out and documented by the manufacturer. Where the health software product is subject to regulatory requirements, external assessment may take place.
Where this document normatively references parts or clauses of other standards focused on safety or security, the manufacturer may use alternative methods to demonstrate compliance with the requirements of this document. These alternative methods may be used if the process results of such alternative methods, including traceability, are demonstrably equivalent and the residual risk remains acceptable.
NOTE The term "conformance" is used in ISO/IEC 12207 where the term "compliance" is used in this document.
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*
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and FDA Staff, October 2, 2014

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software, January 2005

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

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

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
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.