Breaking Down the FDA's 2023 Premarket Cybersecurity Regulations

For some, the FDA’s September 2023 guidelines bring a sigh of relief. For others, it seems like an unclimbable mountain. 

While the previous medical device cybersecurity guidelines were not legally enforceable, the Omnibus bill that went into effect in March 2023 gave them the FDA the legal green light to secure these critical devices. In this report, we take a close look at the newest medical device cybersecurity guidelines as well as what the FDA would like to see before a medical device can gain market approval. 

For those with a mature product security system in place, the latest guidelines have been a long time coming. For those who are still on their journey towards a more mature product security operation, this report will help CPSOs to realign their work– replacing the patchwork of tools with a system that operates harmoniously, automatically, and securely.