The Food and Drug Administration released a new draft guidance April 7 on cybersecurity considerations for medical device makers submitting material for pre-market review.
Due to threats to the healthcare industry becoming more frequent and severe, the FDA premarket guidance, which was initially released in 2014, is being updated to meet the evolving landscape.
The updated guidance is designed to facilitate "an efficient premarket review process," while ensuring medical devices marketed to the healthcare industry are resilient to cybersecurity threats.
The guide covers cybersecurity issues device manufacturers should address in the development and design process, as well as premarket submissions.
The FDA is seeking feedback from healthcare leaders to further develop the insights.