Wednesday, December 2, 2009

FDA watches your website!

Recent warning letters declared products "adulterated" (that's not good!) because of unauthorized claims on the manufacturer's website. In particular, you are not allowed to advertise your product for uses that are not covered by the 510(k) clearance or the PMA. For instance, an powered muscle stimulator that was cleared for pain management and massaging may not be advertised for muscle toning or something similar, even though you could possibly get 510(k) clearance for that intended use also. Forewarned is forearmed: be very careful not to go overboard with your website claims because the FDA is watching!

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