SPADA Meeting Book

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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 799 classified into one of the above listed device classes. A manufacturer who intends to market in 800 the United States a Class I, II, or III device intended for human use, for which a Premarket 801 Approval application (PMA) is not required, must submit to FDA a premarket notification 802 submission (often referred to as a 510(k)), unless the device is exempt from the 510(k) 803 requirements of the FD&C Act and does not exceed the limitations of exemptions for each of the 804 device classification regulations (Section xxx.9 of 21 CFR Parts 862 through 892). 805 In a 510(k) submission, the Agency determines whether or not the device meets the criteria 806 for market clearance. The Agency bases its decision on whether the device is substantially 807 equivalent (SE) (i.e. as safe and as effective) to a legally marketed (predicate) device. Further 808 information on the 510(k) program can be found in the Agency’s guidance “The 510(k) Program: 809 Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (39). Additional 810 information on the Agency’s potential actions from a 510(k) review and the impact on review 811 durations can be found in the guidance “FDA and Industry Actions on Premarket Notification 812 (510(k)) Submissions: Effect on FDA Review Clock and Goals” (40). 813 Regarding nucleic acid-based tests, the Center for Devices and Radiological Health (CDRH) 814 at FDA has extensive experience with clearing and approving this device type. Assay developers 815 are encouraged to use the Agency’s publicly available database that contains 510(k) submissions 816 on this device type (e.g., microbial tests) to determine if an appropriate predicate for their 817 submission can be established (41). This resource also provides the corresponding SE 818 determination Decision Summaries that potential sponsors may review as guidance towards 819 appropriate device specific studies (e.g., analytical and clinical validation). A relevant example 820

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