Are you a manufacturer of medical devices?
FDA 510k is the section of the Food Drug and Cosmetic Act that requires device developers to notify FDA of their intent to market a device through submission of a Premarket Notification.Companies intending to introduce certain classes of medical devices into the US market must submit a 510(k) to the FDA. After FDA’s clearance that medical devices can be manufactured and distributed in the US. Changes in the 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 the FDA.
FDA 510(k) Submission guidance – does my product need an FDA 510k?
