Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 13-104
Standard
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
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.

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.
-
-