Mar 29, 2023·FDA · Final GuidanceWithdrawnMedium impact
FDA Refuse-to-Accept Policy for Cyber Devices (2023)
When Section 524B took effect, the FDA said it would not refuse submissions for missing 524B content until October 1, 2023, and would work with sponsors during review instead. After that date, submissions missing the required cybersecurity content could be refused.
What changed
- Set October 1, 2023 as the date the FDA could begin refusing cyber device submissions that lack 524B content.
- The transition period is over; the policy has since been folded into later premarket guidance.
Action for manufacturers
Treat missing 524B content as a refuse-to-accept risk. Check every cyber device submission against the eSTAR cybersecurity section before you send it.