FDA Warning letters

One of my client's distributors recently got a warning letter from the FDA for illegal claims on his websites. If you advertise your medical device for intended uses that are not included in your 510(k) clearance, your device is "adulterated". The FDA has an array of sanctions available that they can impose, from just "clean up your act" to "recall all products". Things get worse, of course, if your device causes unsafe situations or patient injuries. The FDA is very active researching websites and advertising materials for exaggerated claims, but many of these FDA investigations result from competitors or unhappy customers complaining. So be careful!