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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 032 Date of Entry 08/06/2013 
FR Recognition Number 13-62
Standard
IEC  TR 62443-3-1 Edition 1.0 2009-07
Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
Scope/Abstract
This part of IEC 62443 provides a current assessment of various cybersecurity tools, mitigation counter-measures, and technologies that may effectively apply to the modern electronically based IACSs regulating and monitoring numerous industries and critical infrastructures. It describes several categories of control system-centric cybersecurity technologies, the types of products available in those categories, the pros and cons of using those products in the automated IACS environments, relative to the expected threats and known cyber vulnerabilities, and, most important, the preliminary recommendations and guidance for using these cybersecurity technology products and/or countermeasures.
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.
Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device
Relevant FDA Guidance and/or Supportive Publications*
NIST Special Publication 800-82, Guide to Industrial Control Systems (ICS) Security, June 2011

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
 CDRH Division of Medical Device Cybersecurity
  FDA/OC/CDRH/OST/ORR
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  CyberMed@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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