Regulatory reference
The FDA publishes the standards and editions it recognises, but only in English and in a database that can be difficult to search. Here is a daily updated list of the standards most often used in medical device registration.
Updated on 21/10/2026
19 standards monitored
Quality management system
The basis of the QMS and, since 02/02/2026, incorporated by reference into the FDA QMSR.
Risk management
Medical devices - Application of risk management to medical devices
Recognition 5-125since 23/12/2019
Required in dossiers for every class; it provides the basis for the risk management file.
Auditing guidelines
Revised in 2026.
Clinical investigation
Clinical investigation of medical devices for human subjects - Good clinical practice
Recognition 2-282since 21/12/2020
Design and conduct of a device clinical study.
Biological evaluation: plan
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
Also applicable: Fifth edition 2018-08
Recognition 2-313since 25/05/2026
The starting point for the entire biological evaluation; changes here affect the test plan.
Cytotoxicity
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Recognition 2-245since 23/12/2016
Chemical characterisation
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
Recognition 2-298since 07/09/2026
Biocompatibility of breathing gas pathways
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
Recognition 1-173since 29/05/2024
Software life cycle
Medical device software - Software life cycle processes
Recognition 13-79since 14/01/2019
Mandatory for SaMD and embedded software.
Usability engineering
Medical devices - Part 1: Application of usability engineering to medical devices
Recognition 5-129since 06/07/2020
The FDA's human factors guidance now aligns with this standard.
Healthcare software cybersecurity
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Recognition 13-122since 19/12/2022
Medical electrical equipment safety
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Re
Also applicable: First Edition 2003
Recognition 19-49since 03/04/2023
Electromagnetic compatibility
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Recognition 19-36since 21/12/2020
Sterile product packaging
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
Also applicable: Second edition 2019-02
Recognition 14-594since 18/12/2023
Ethylene oxide sterilisation
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
Recognition 14-529since 15/07/2019
Radiation sterilisation
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Also applicable: First edition 2006-04-15
Recognition 14-611since 26/05/2025
Steam sterilisation
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Recognition 14-333since 04/04/2016
Labelling symbols
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)]
Also applicable: Fourth edition 2021-07
Recognition 5-148since 22/12/2025
Information supplied by the manufacturer
Medical devices - Information to be supplied by the manufacturer
Also applicable: First edition 2021-04 Corrected version 2021-12
Recognition 5-149since 25/05/2026
Edition source: the Recognized Consensus Standards FDA database, checked automatically every day. The standards themselves belong to ISO and IEC, require purchase and are not reproduced here. This page is a supporting reference and does not replace consulting the standard or the competent authority.
Next step
When a new edition of a standard is published, dossiers, procedures and risk files must keep up. HSC Global reviews the changes and turns them into an action plan with deadlines and responsibilities.
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