Arlington, Virginia--(Newsfile Corp. - March 24, 2026) - The Food and Drug Administration (FDA) recently added the Association for the Advancement of Medical Instrumentation's primary guidance document on cybersecurity for artificial intelligence (AI) or machine learning (ML)-enabled medical devices to its database of recognized consensus standards.
AAMI CR515:2025; Cybersecurity considerations unique to machine learning-enabled medical devices was released in 2025 to fill existing gaps in industry guidance. Produced by AAMI's Artificial Intelligence Committee, at the time chaired by Dr. Jesse Ehrenfeld and Pat Baird of Philips, the guidance addresses cybersecurity threats that can arise from or during data collection, product design, product deployment, product use, and maintenance of AI or ML-enabled medical devices.
In recognition of the issue's urgency, the Artificial Intelligence Committee chose to produce an AAMI consensus report (CR) as opposed to a more lengthy technical information report (TIR) or standard. AAMI consensus reports are developed specifically to provide concise, prompt, and practical guidance on narrowly focused topics of high importance to the health technology community. In the case of CR515, the rapid development and emergence of AI and ML-enabled cybersecurity threats necessitated the speedy production of a consensus report rather than a TIR or consensus standard.
FDA's full recognition of CR515 is a major milestone for AAMI's impact in the AI sphere. Matt Williams, AAMI Vice President of Standards, said, "FDA's recognition of CR515 is a welcome validation not just of AAMI's efforts to produce a guidance document that meets the moment, but of our mission to support the safe and effective use of health technology for new and legacy medical devices alike."
Other AAMI-Affiliated Standards Recognized by FDA
The FDA also added a cluster of ISO guidance documents related to anesthesiology and cardiovascular health to its recognized consensus standards database.
International Secretariat and U.S. TAG administered by AAMI:
- ISO 17510 Second edition, 2025-11: Medical devices - sleep apnea breathing therapy - masks and application accessories
- ISO 7376 Third edition, 2020-08: Anaesthetic and respiratory equipment - laryngoscopes for tracheal intubation - amendment 1: clarification of optical output and illumination requirements
- ISO 80601-2-70 Third edition, 2025-11: Medical electrical equipment - part 2-70: particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
- ISO 7376-2 First edition, 2025-09: Anaesthetic and respiratory equipment - part 2: Video laryngoscopes
- ISO 19223-2 First edition, 2025-04: Lung ventilators and related equipment - vocabulary and semantics - part 2: high frequency and jet ventilation
- ISO 19223-3 First edition, 2025-09: Lung ventilators and related equipment - vocabulary and semantics - part 3: respiratory care
- ISO 60601-2-31 Edition 3.0, 2020-01: Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- ISO 60601-2-34 Edition 4.0, 2024-10: Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ISO 80601-2-49 Edition 1.1, 2024-09 CONSOLIDATED VERSION: Medical electrical equipment - Part 2-49: particular requirements for the basic safety and essential performance of multifunction patient monitors
- ISO 80369-6 Second edition, 2025-05: Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications
- 80369-1 Third edition, 2025-10: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
- ISO 15223-1 Fourth edition, 2021-07 [Including AMD1: 2025]: Medical devices - symbols to be used with information to be supplied by the manufacturer - part 1: general requirements
U.S. TAG administered by AAMI:
- ISO 10993-4 Third edition, 2017-04 [Including AMD1:2025]: Biological evaluation of medical devices - part 4: selection of tests for interactions with blood
- ISO 7886-2 Second edition, 2020-04: Sterile hypodermic syringes for single use - part 2: syringes for use with power-driven syringe pumps
- ISO 1135-4 Seventh edition, 2025-05: Transfusion equipment for medical use-part 4: transfusion sets for single use gravity feed
Contact:
Daniel Visnovsky
DVisnovsky@aami.org
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Source: Association for the Advancement of Medical Instrumentation
