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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 049 Date of Entry 06/07/2018 
FR Recognition Number 13-104
UL ANSI  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
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*
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.

Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued December 2016.

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
Standards Development Organizations
UL Underwriters Laboratories, Inc. http://www.ul.com/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.