Advertising of medical devices

More and more frequently I see reports about the FDA cracking down on off-label advertising, mostly of drugs but also of devices. These are advertisements that recommend the product for use(s) that are not FDA cleared or approved. And you know what – those ads are illegal! Many times advertising executives do not fully understand the regulations and step over the line. The FDA has, in 2004, published a (draft) guidance for "Consumer-Directed Broadcast Advertising of Restricted Devices". This document makes excellent reading on a rainy afternoon, and it contains recommendations from the FDA about what should be in those ads (and what shouldn't). These recommendations contain elements that are also applicable to written advertisements. Note that ads on your webpage are regarded as "broadcast advertising"!