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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 13-96
Standard
UL ANSI  2900-1 First Edition 2017
Standard for Safety, Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
Scope/Abstract
1.1 This standard applies to network-connectable products that shall be evaluated and tested for vulnerabilities, software weaknesses and malware.

1.2 This standard describes:
a) Requirements regarding the software developer (vendor or other supply chain member) risk management process for their product.
b) Methods by which a product shall be evaluated and tested for the presence of vulnerabilities, software weaknesses and malware.
c) Requirements regarding the presence of security risk controls in the architecture and design of a product.

1.3 This standard does not contain requirements regarding functional testing of a product. This means this standard contains no requirements to verify that the product functions as designed.

1.4 This standard does not contain requirements regarding the hardware contained in a product.
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.

NOTE: Conformance to this standard may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act or the recommendations in the (1) listed below (Relevant FDA Guidance). Manufacturers should consider the information contained within these resources in their assessment of cybersecurity for their device.
Public Law, CFR Citation(s) and Procode(s)*
Federal Food, Drug, and Cosmetic Act, Section 524B ENSURING CYBERSECURITY OF DEVICES
Relevant FDA Guidance and/or Supportive Publications*
1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.

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

3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

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/
  --
  CyberMed@fda.hhs.gov
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)
Software/Informatics
*These are provided as examples and others may be applicable.
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