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US FDA pre-submission meeting proceeds

2019.11.07.

2019.11.07.

[US FDA pre-submission meeting proceeds]


QuantaMatrix held a pre-submission meeting in Silver Spring, Maryland, on November 6 regarding the licensing documents of the FDA for a rapid antimicrobial susceptibility test (dRAST). The meeting was attended by the director in the Office of In-Vitro Diagnostics and Radiological Health (CDRH) of the Center for Devices and Radiological Health (CDRH) under the U.S. FDA, as well as the director of development and licensing at QuantaMatrix. Through this discussion, we made it clear that FDA licensing track for dRAST is 510(k). We obtained a very positive review that the performance test method we presented for 510(k) submission is eligible as the basis for 510(k) licensing. Based on the results of the meeting, we want to establish an efficient FDA licensing strategy to advance dRAST’s entry into the U.S market.