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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 13-104
Standard
ANSI UL 2900-2-1 First Edition 2017
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
Scope/Abstract
1.1 This security evaluation standard applies to the testing of network connected components of healthcare systems. It applies to, but is not limited to, the following key components:

a) Medical devices;
b) Accessories to medical devices;
c) Medical device data systems;
d) In vitro diagnostic devices;
e) Health information technology; and
f) Wellness devices.
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 Food and Drug Administration Staff, Issued October 2014.

Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, Issued December 2016.
FDA Technical Contacts
 Brian Fitzgerald
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2579
  Brian.Fitzgerald@fda.hhs.gov
 Linda Ricci
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-6325
  linda.ricci@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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