![]() Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB).Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 585KB).See the links on the left side of this page to find monthly listings of 510(k)s cleared by FDA. Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. This is known as Premarket Notification - also called PMN or 510(k). ![]() Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. ![]()
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