US: Global Medical Device Cybersecurity Standards and Guidance Documents

US FDA medical device cybersecurity guidance

  • To sell in the US, there are two essential FDA medical device software cybersecurity documents to be aware of and plus one standard.

  • US FDA GuidanceContent of premarket submissions for management of cybersecurity in medical devices If you’re in the early stages of design and working toward an eventual regulatory submission this brief guidance from 2014 will be an essential reference document.

  • US FDA GuidancePostmarket management of cybersecurity in medical devices Issued in 2016, this FDA guidance is far more substantial and outlines best practices for establishing an effective cybersecurity program, including cybersecurity remediation and reporting.

  • UL2900-2-1Safety Software Cybersecurity for Network-Connectable Products In mid-2018 the FDA recognized UL 2900-2-1, a cybersecurity testing standard for connected medical devices. It calls for “structured penetration testing, evaluation of product source code, and analysis of software bill of materials.” It was slightly updated in June 2020 to address issues related to telemedicine equipment entering hospitals for COVID-19 response.

Internationally recognized medtech cybersecurity standards and guidance

  • IMDRF WG/N60: Principles and practices for medical device cybersecurity This 46-page document, published in March 2020 by the International Medical Device Regulators Forum, strives to harmonize medical device cybersecurity principles and best practices internationally. It’s the first IMDRF document to focus on the topic and it goes well beyond recommendations for manufacturers by also including advice on reducing cybersecurity risks to healthcare providers, regulatory and users. There is plenty of overlap with the two FDA documents mentioned above but it is an essential document for you to study.

  • ISO/IEC 27001:2013 – Information security management There are numerous standards within the 27000 family so you’ll want to review them here. The most essential one is ISO/IEC 27001. Published way back in 2013 – light years ago in the digital age – it shows you how to build a systematic approach for protecting all information in your company, including your products. Because this is not a product-specific cybersecurity standard it’s best to think of it as “horizontal standard,” analogous to ISO 13485.

  • IEC 62304:2006– Medical device software life cycle processes IEC 62304 assumes that you are applying ISO 14971 risk management and have a quality management system in place that complies with ISO 13485 or the US FDA Quality System Regulation (21 CFR Part 820). You can think of ISO 14971 as the overarching risk management process that covers all product development activities, while IEC 62304 is a subset of that effort, focusing on software risk management, configuration management and problem resolution. The original version was released in 2006 (and slightly modified in 2015) but a revised version is tentatively scheduled for release in mid-2021.

  • AAMI TIR97:2019 – Principles for medical device security: Postmarket risk management This Technical Information Report, released in September 2019, provides guidance on how medical device manufacturers should manage security risk throughout the entire lifecycle of a medical device. It has been updated to align with ISO 14971:2019.

  • AAMI TIR57:2019 – Principles for medical device security—Risk management This report, also released in September 2019, provides guidance on specific methods manufacturers can use to perform information security management in the context of ISO 14971:2019. It is intended to be a companion to TIR97.


Other medical device cybersecurity-related standards….

  • Many additional product-specific software development documents exist, with just a few notable examples below.

  • NIST Cybersecurity Framework Version 1.1

  • CLSI, AUTO11-A – IT Security of In Vitro Diagnostic Instruments and Software Systems

  • ISO/TR 80001-2-2:2012 – Application of risk management for IT networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

  • IEC TS 62443-1-1 Edition 1.0 2009-07 – Industrial communication networks – Network and system security – Part 1-1: Terminology, concepts and models.

  • IEC 62443-2-1 Edition 1.0 2010-11 – Industrial communication networks – Network and system security – Part 2-1: Establishing an industrial automation and control system security program

  • IEC/TR 62443-3-1 Edition 1.0 2009-07 – Industrial communication networks – Network and system security – Part 3-1: Security technologies for industrial automation and control systems.

Source : US FDA website

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