Why FDA's Medical Device Cyber Recommendations 'Have Teeth'

The inclusion of a new secure product development framework for manufacturers is a significant addition to recently updated Food and Drug Administration draft guidance for the cybersecurity of premarket medical devices, says attorney Linda Malek of the law firm Moses & Singer LLP. "To the extent that these are recommendations from the FDA in terms of how devices should implement cybersecurity measures in order to comply with the larger regulatory requirements, the FDA is indicating what its expectations are and what it will be looking at as it reviews premarket applications," she says.