Groups Ask FDA to Rethink Some Medical Device Cyber Proposals

Some of the associations submitting comments on FDA’s draft guidance suggested modifications to the agency’s call for a “cybersecurity bill of materials,” or CBOM, that medical device makers would need to submit to the FDA for premarket review. Some also critiqued FDA’s proposal to define two tiers of medical devices based on their cybersecurity risk (see FDA Calls for Cybersecurity Bill of Materials).