Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions

Originally recorded on October 12, 2023
On September 26, 2023 the FDA issued an updated final guidance entitled, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." Cybersecurity is an important part of patient safety, and after releasing a premarket guidance in 2014 and a complementary postmarket guidance in 2016, FDA has released this updated approach to replace the 2014 premarket guidance and address the rapidly evolving landscape and increased understanding of emerging threats.
The changes emphasize the importance of ensuring that devices are secure by design and designed to be capable of mitigating emerging cybersecurity risks throughout the total product lifecycle. This new guidance document more clearly outline FDA’s recommendations for premarket submission information to address cybersecurity concerns.
What do medical device manufacturers need to understand about the guidance? MedCrypt’s FDA experts Naomi Schwartz and Seth Carmody unpack the guidance in a conversation lead by CEO Mike Kijewski.