SPADA Docs

Regarding nucleic acid-based tests, the Center for Devices and Radiological Health (CDRH) 855 at FDA has extensive experience with clearing and approving this device type. Assay developers 856 are encouraged to use the Agency’s publicly available database that contains 510(k) submissions 857 on this device type (e.g., microbial tests) to determine if an appropriate predicate for their 858 submission can be established (43). This resource also provides the corresponding SE 859 determination Decision Summaries that potential sponsors may review as guidance towards 860 appropriate device specific studies (e.g., analytical and clinical validation). A relevant example 861 of SE determination for an agent detection device is the cleared Joint Biological Agent 862 Identification and Diagnostic System (JBAIDS) Anthrax Detection System (44). Additionally, 863 the FDA has published a guidance document entitled, “Highly Multiplexed 864 Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices- 865 Guidance for Industry and Food and Drug Administration Staff” that may be of particular 866 relevance to developers of nucleic acid-based agent diagnostic devices (45). This document 867 recommends studies (e.g., analytical) for establishing the performance characteristics of Highly 868 Multiplexed Microbiological Devices (HMMDs). FDA considers these recommended studies to 869 be relevant for premarket notifications (e.g., 510(k) or de novo (see proceeding section on De 870 Novo for further information on this regulatory pathway)). 871 Note that assays involving biothreat agents/MCMs are limited in what is publicly disclosed 872 in decision summaries by nature of the sensitivity of information contained in these device type 873 submissions. As such, sponsors are encouraged to discuss with FDA any submission concerns or 874 specific requirements that may not be informed through decision summary reviews (see 875 aforementioned pre-submission program).

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