FDA Issues Cybersecurity Draft Guidance, Wants Devices Designed Securely

By MedTech Intelligence Staff

With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.

Learn more about Connected Devices by participating in the MedTech Intelligence Series, Connected Care: Digital Health, Wearables & Connectivity | Telemedicine and Healthcare Outside the Hospital As the use of wireless, portable and connected medical devices continues to increase, the FDA wants to make sure that devices are not only designed securely but also that any cybersecurity risks can be mitigated throughout the total product lifecycle. Ultimately, the agency wants marketed medical devices to be “sufficiently resilient” to any cybersecurity threats. With that, the agency has issued the draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. This draft guidance replaces the 2018 draft version.

“Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm,” states FDA.

Once finalized, the guidance aims to provide recommendations on cybersecurity considerations for medical devices; aid the industry in finding cybersecurity issues during the design and development process; and give recommendations for documentation in device premarket submissions.

Industry is encouraged to submit comments on the draft by July 7, 2022.

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