For six months, medical device makers have had to comply with new cybersecurity regulations aimed at hardening medical devices against cyber attacks, but the US Food and Drug Administration has largely refrained from using its “refuse to accept” power up to now.

On Oct. 1, the FDA’s grace period — during which the agency stated it would try not to use its ability to reject medical devices that lack appropriate cybersecurity controls and a post-market patching capability — will end. The manufacturers of medical cyber devices must now submit plans to monitor and patch post-market cybersecurity vulnerabilities, have a process in place for the secure design and development of devices, and provide a software bill of materials (SBOM) to the FDA. Those who do not satisfy the requirements could have their devices rejected on the grounds that they pose too great a cyber risk.