How do you really know where your business stands in regard to FDA compliance?
Are you a manufacturer of dental devices? Is your dental lab current with the latest 510(k) news? A 510(k) is the section of the Food Drug and Cosmetic Act that requires product developers to notify FDA of their intent to market a device. Changes in technology used to manufacture a device or a change in the intended use of the medical device can also require submission of a 510(k) premarket notification to FDA. Class I, II or III medical devices that do not require Premarket Approval can be placed on the market, but they must be cleared by the FDA prior to marketing and distribution.Manufacturers or dental laboratories intending to manufacture dental devices may only use materials and components that are compliant with FDA regulations and must verify existence of a 510(k) for patient contact materials that require a 510(k) clearance. Examples of devices that require this clearance are: