SPADA Meeting Book

of SE determination for an agent detection device is the cleared Joint Biological Agent 821 Identification and Diagnostic System (JBAIDS) Anthrax Detection System (42). Additionally, 822 the FDA has published a guidance document entitled, “Highly Multiplexed 823 Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices- 824 Guidance for Industry and Food and Drug Administration Staff” that may be of particular 825 relevance to developers of nucleic acid-based agent diagnostic devices (43). This document 826 recommends studies (e.g., analytical) for establishing the performance characteristics of Highly 827 Multiplexed Microbiological Devices (HMMDs). FDA considers these recommended studies to 828 be relevant for premarket notifications (e.g., 510(k) or de novo (see proceeding section on De 829 Novo for further information on this regulatory pathway)). 830 Note that assays involving biothreat agents/MCMs are limited in what is publicly disclosed 831 in decision summaries by nature of the sensitivity of information contained in these device type 832 submissions. As such, sponsors are encouraged to discuss with FDA any submission concerns or 833 specific requirements that may not be informed through decision summary reviews (see 834 aforementioned pre-submission program). 838 Innovation Act (FDASIA), sponsors that believe their device is appropriate for classification into 839 Class I or Class II and determines, based on currently available information, there is no legally 840 marketed predicate device , can submit a De Novo request without a preceding 510(k) and Not 841 Substantially Equivalent (NSE) decision (i.e., “Direct De Novo ”). The De Novo request must 842 include a description of the device and detailed information and reasons for any recommended 843 835 836 7.2.3 De Novo Classification Process 837 With the modification to Section 513(f)(2) of the FD&C Act through the FDA Safety and

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