Dodging the Pitfalls of FDA Advertising, Marketing Rules

Devicemakers can avoid being cited by the FDA for advertising and labeling deviations by making sure they have substantial data to back up claims and substantiate a device’s intended use, according to attorney Jeffery Shapiro of Hyman, Phelps, & McNamara.
For 510(k) devices, information based on new research can sometimes be added to promotional materials without filing a new 510(k) if records support the change.
Devices & Diagnostics Letter