ARTICLE SUMMARY:
In this week’s roundup: New FDA cyber law kicks in, but the agency will offer temporary leeway; on the lookout for EPA’s ethylene oxide rule and FDA’s predetermined change control plan draft guidance; FDA issues COVID-19 transition plans and EU posts Q&A guide for its MDR extensions; more updates from the US, Europe, Malaysia, and Australia.
Top Pick
New FDA cyber law and leeway
New statutory requirements for cybersecurity information that must be included in FDA premarket device submissions officially take effect today, March 29. The US omnibus bill enacted at the end of 2022 explicitly mandates for the first time that device manufacturers include a cyber vulnerability monitoring plan and software bill of materials (SBOM), among other details, in submissions for devices that can connect to the internet. But CDRH Director Jeff Shuren says the center plans to do some hand-holding for companies in the near term.
