SPADA Draft Documents

778

The 510(k) Program

Premarket notification is the process by which a new device (i.e. post-amendments device) is 779 classified into one of the above listed device classes. A manufacturer who intends to market in 780 the United States a Class I, II, or III device intended for human use, for which a Premarket 781 Approval application (PMA) is not required, must submit to FDA a premarket notification 782 submission (often referred to as a 510(k)), unless the device is exempt from the 510(k) 783 requirements of the FD&C Act and does not exceed the limitations of exemptions for each of the 784 device classification regulations (Section xxx.9 of 21 CFR Parts 862 through 892). 785 In a 510(k) submission, the Agency determines whether or not the device meets the criteria 786 for market clearance. The Agency bases its decision on whether the device is substantially 787 equivalent (SE) (i.e. as safe and as effective) to a legally marketed (predicate) device. Further 788 information on the 510(k) program can be found in the Agency’s guidance “The 510(k) Program: 789 Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (39). Additional 790 information on the Agency’s potential actions from a 510(k) review and the impact on review 791 durations can be found in the guidance “FDA and Industry Actions on Premarket Notification 792 (510(k)) Submissions: Effect on FDA Review Clock and Goals” (40). 793 Regarding nucleic acid-based tests, the Center for Devices and Radiological Health (CDRH) 794 at FDA has extensive experience with clearing and approving this device type. Assay developers 795 are encouraged to use the Agency’s publicly available database that contains 510(k) submissions 796 on this device type (e.g., microbial tests) to determine if an appropriate predicate for their 797 submission can be established (41). This resource also provides the corresponding SE 798 determination Decision Summaries that potential sponsors may review as guidance towards 799 appropriate device specific studies (e.g., analytical and clinical validation). A relevant example 800

41