Comparative Claims: Legally Permissible, But Proceed with Care

September 1, 2004By: Jeffrey K. Shapiro Download PDF

Legally, medical device companies may promote their devices with claims of superiority over competing products-or over previous versions of the company’s own products. However, FDA scrutinizes such claims carefully. The agency views comparisons with suspicion, believing that they are potentially misleading and seldom complete. Over the years, FDA has issued numerous warning letters alleging that comparative claims are false, misleading, or otherwise violative.