FDA releases medical device cybersecurity draft guidance

The U.S. Food and Drug Administration (FDA) has released draft guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The guidance emphasizes the importance of safeguarding medical devices from cybersecurity threats throughout their lifecycle. It replaces the previous guidance issued in 2018. The FDA is seeking comments on the draft guidance until July 7, 2022. This draft guidance reflects the increasing significance of cybersecurity in the healthcare sector as more patients benefit from connected care.