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Advertising Medical Devices In the US

Under Federal Food, Drug, And Cosmetic Act (FFDCA) Medical Devices are to be sold only for FDA cleared (510k) or approved (PMA) Intended Uses.  If a device is promoted for an indication other than what was approved they risk being charged with adulteration or misbranding.  This enforcement policy also applies to devices that are sold with false or misleading claims, and counterfeits.

FEDERAL TORT CLAIMS ACT (FTCA) 

Deceptive advertising is also equally enforced under The Federal Tort Claims Act (FTCA) who prohibit false advertising – misleading in a material respect.  While the FDA is mainly concerned with the labeling of devices, the FTC requires that advertising be truthful – with substantiated objective claims – and not be misleading.

Unlike the FDA who participate and regulate preapproval claims, the FTC are primarily responsible for postmarket claims.  Civil liability can be brought upon individuals or the organization – especially where the infringement was done knowingly (or with disregard for the truth).

 FDA REQUIREMENTS 

If your device is a PMA device FDA must approve the labeling, unlike 510k cleared devices.  However, 510k devices still require that you submit an “Indications for Use” statement at the time of submission.  This has prompted some manufacturers to construct their Indications for Use statement in a general manner in the hope of covering a wider use category in the event of forthcoming changes.  Note that this practice has it’s pitfalls because unless you specify the use in the official statement given to the FDA – they will consider that your device does NOT follow it’s clearance.  This is true also for submissions where substantiating data was provided in the submission.

The FDA also states that changes in the “Indications for Use” requires resubmission of your 510k or in the case of PMA, a manufacturer is required to submit a PMA supplement.

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