FDA’s Cybersecurity Requirements for Medical Devices
(Thursday, September 28, 2023)
Cybersecurity requirements for FDA-regulated devices are evolving rapidly to stay in step with technological developments. This week the FDA released a detailed guidance document addressing several security issues around medical devices connected to the internet currently in development. The directions in this guidance document could append the ongoing development plans for internet-connected medical devices or combination products by specifying the documents to be submitted to the pre-market applications. This guidance is not retrospectively applicable to devices already cleared or approved by the FDA.
Cybersecurity of medical devices is not a new concern; the FDA has been talking about it for more than a decade. The first guidance on the topic was released about 10 years ago in 2014. However, in the last decade, there has been an increasing understanding of cyber threats and mitigation strategies for the same. The new guidance is focused on the deployment of threat mitigations throughout the total product lifecycle (TPLC). The new guidance builds on the earlier guidance document from 2014 to list the various elements of device design that can ensure that devices can mitigate emerging cybersecurity risks throughout the TPLC. The guidance also introduces a Secure Product Development Framework (SPDF) which is defined as a set of processes that reduce the number and severity of vulnerabilities in products throughout the device lifecycle.
FDA recommends that premarket applications for devices with cybersecurity risks should include documentation of the planned and implemented cybersecurity risk mitigation measures in the SPDF format. An SPDF encompasses all aspects of a product’s lifecycle, including design, development, release, support, and decommission. Cybersecurity risk assessment should be included in the quality risk assessment and management plans and quality systems. FDA believes that the implementation and adoption of SPDF would effectively address most cybersecurity risks. An SPDF involves three stages: risk identification and management, security architecture, and cybersecurity testing. Devices must implement cybersecurity management plans and labeling must include the potential cybersecurity risks.
Over the last few years, since the formation of the Digital Health Center for Excellence at the FDA, the FDA has held numerous interactions with the developers of these devices. This guidance is a collection of the lessons from those interactions. It includes detailed lists of most major risk areas and suggestions for mitigation of the same. The appendices of the guidance, which span about half of the length of the document, provide detailed descriptions of various control categories and associated recommendations, documentation requirements for FDA submissions, and other important suggestions for the pre-market applications.
This Guidance Document is a required read for developers of internet-connected devices at all stages of development.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC