The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for their products.
FDA said Thursday the recommendations in the guidance document aim to facilitate the review process for premarket submissions and reduce the risk of patient harm associated with devices with cyber vulnerabilities.
The document covers several premarket device submissions such as premarket approval applications; 510(k) premarket notifications; de novo requests; product development protocols; and applications for humanitarian device exemptions.
The agency will accept comments within 150 days of notice publication in the Federal Register.
The draft document came days after FDA teamed up with the Department of Homeland Security to address cyber threats in medical systems.
Mitre worked with FDA on a playbook that seeks to ensure patient safety by providing a framework for health delivery organizations to prepare for and respond to cyber breaches involving medical devices.
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