Cybersecurity déjà vuDecember 11, 2018 Download PDF
On October 18, FDA issued a new draft guidance document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (“Draft Guidance”). When final,it will supersede the 2014 guidance document of the same name (“Current Guidance”).
The Draft Guidance expands significantly the recommendations for cybersecurity design expectations, level of detail used in describing a device’s cybersecurity considerations and the amount and type of documentation required in a premarket submission.
- Adrienne R. Lenz
Senior Medical Device Regulation Expert