SPADA Docs

( c ) Class III .—Device for which general controls, by themselves, are insufficient and for 833 which there is insufficient information to establish special controls to provide reasonable 834 assurance of the safety and effectiveness of the device. Class III devices typically require 835 premarket approval.

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7.2.2 The 510(k) Program

Premarket notification is the process by which a new device (i.e. post-amendments device) is 839 classified into one of the above listed device classes. A manufacturer who intends to market in 840 the United States a Class I, II, or III device intended for human use, for which a Premarket 841 Approval application (PMA) is not required, must submit to FDA a premarket notification 842 submission (often referred to as a 510(k)), unless the device is exempt from the 510(k) 843 requirements of the FD&C Act and does not exceed the limitations of exemptions for each of the 844 device classification regulations (Sections 862.9 through 892.9 of 21 CFR Parts 862 through 845 892). 846 In a 510(k) submission, the Agency determines whether or not the device meets the criteria 847 for market clearance. The Agency bases its decision on whether the device is substantially 848 equivalent (SE) (i.e. as safe and as effective) to a legally marketed (predicate) device. Further 849 information on the 510(k) program can be found in the Agency’s guidance “The 510(k) Program: 850 Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (41). Additional 851 information on the Agency’s potential actions from a 510(k) review and the impact on review 852 durations can be found in the guidance “FDA and Industry Actions on Premarket Notification 853 (510(k)) Submissions: Effect on FDA Review Clock and Goals” (42). 854

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