Mar 13, 2024·FDA · Draft GuidanceWithdrawnLow impact
FDA Draft Section 524B Guidance Updates (2024)
In March 2024 the FDA published a draft explaining how it reads Section 524B, including what counts as a cyber device. That content has since been brought into the final premarket cybersecurity guidance.
What changed
- Explained the FDA's reading of the cyber device definition in Section 524B.
- Superseded once its content was folded into final guidance.
Action for manufacturers
Cite the current final guidance, not the 2024 draft.