MDMA Suggests Changes to Cybersecurity Guidance

The Medical Device Manufacturers Association (MDMA) has several suggested changes for an FDA draft guidance on select updates for the premarket cybersecurity guidance. MDMA says that while the draft says that upon finalization it will supersede an existing guidance, MDMA recommends that the new content and concepts in the draft be fully incorporated into the current premarket cybersecurity guidance, rather than being positioned as a standalone section attached at the end of the document. “We believe that this would optimize the usability and comprehensibility of such final guidance for all stakeholders,” the association says.

It also requests additional clarifying information for several areas of the draft and examples or other clarification for several terms or considerations in it.

MDMA says it has concerns and would like to offer proposed solutions for the coordinated vulnerability disclosures that are required in the guidance.