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Device Claims...
Information you as the manufacturer publish regarding your medical device falls into
· news, media (which has been ruled under freedom of press. This includes articles written by third parties about your product.)
· claims this is the advertisement, marketing posters displayed at trade shows, brochure, written copy used to induce sales.
· Labels. These are the paper labels on your product, computer displays posted on the screen of a control computer, user manual, service bulletins, etc.

Your sales promises, expected results and advertised benefits are your product claims. These claims must conform to FDA requirements and must reflect the actual performance of the product. The stronger your claims the more information must be produced to support these claims. You should avoid unsupported product claims. The FDA could make you an example.

copyright by Compliance Consultants, Stamford, CT USA, September 2001