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Advertising Medical Devices In the US

...cont'd

INTERNET LABELING

 Under 21 CFR 801.4 the FDA look at all circumstances surrounding distribution when determining intended use of devices.  There have been cases where warning letters have alleged that the manufacturer promoted “off-label” uses of their devices (on the Internet).

 Many challenges that manufacturers have therefore, result where particular clearances have been given for different foreign countries.  These websites however can be accessed from the United States and hence present the manufacturer with the dilemma of posting their information.

 The best way to post information on the Internet is to: 

Provide separate links to the different regulatory regions (countries) – then present the information that is relevant to that country, AND

Indicate US regulatory status of the device (in the event a visitor [from US] accidentally lands on the webpage)

HOW DOES THE FDA ENFORCE ADVERTISING OF DEVICES?

 The FDA probably do not have employees actively seeking misbranding of devices.  That is to say they do not have them do this full time.  However, there are many ways the FDA learns about adulteration and misbranding.

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