FDA is committed to enforcement regarding advertising and promotional violations involving regulated products. Misleading or unsubstantiated performance claims are always a concern to both FDA and FTC.
Warning Letters have and will continue to be a common enforcement tool used by FDA to address product claims that breach the scope of FDA cleared/approved indications.
Using direct guidance from FDA and FTC, ComplianceAcuity has spent extensive efforts becoming fluent in the challenging arena of advertising and promotional regulation.
We are proud of our robust experience in successfully partnering with Marketing and Sales teams to develop advertising materials and websites that deliver a compelling promotional impact AND satisfy FDA and FTC promotional guidelines.
“ComplianceAcuityhelped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place”
- Director of Quality, Class II & III Devices