"Starting Oct.1, significant changes are going into effect for medical device manufacturers—and medical device cybersecurity experts have mixed opinions on whether device makers are ready for the change.
The FDA's "Refuse to Accept" policy relates to the FDA's review of medical devices and their premarket submission notification, known as the 510(k) submission process (named after the submission form). Under the new Refuse to Accept policy, the FDA will automatically begin rejecting premarket medical device submissions if they fail to meet the FDA's expected description of device security measures, including security controls, handling vulnerability disclosure with security researchers, and a software bill of materials (SBOM).
The new FDA regulatory powers behind the policy came from legislation signed into law in December that gave the FDA more substantial authority over what the agency can require from device makers as they work to get regulatory approval to bring their devices to market."
https://nexusconnect.io/articles/fdas-refuse-to-accept-policy-is-here