Friday, October 20, 2017 9:45:59 PM
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=529643&lpcd=NAE
Clicking on the "Product Code" link indicates that AC5 w/out drug and/or biologic is "510(K) Exempt."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5643
Since AC5 wo meds is 510(K) Exempt, ARTH would not have been required to file a 510(K). Since they've told us they filed one, this means that their application must refer to some other device.
https://ir.archtherapeutics.com/press-releases/detail/495/arch-therapeutics-announces-510k-submission-to-the-u-s
My speculation is that the 510(K) application we heard about from ARTH must have been for AC5 WITH drug and/or biologic.
Would ARTH have to submit multiple applications, one for every drug or biologic that AC5 might be combined with? Since their PR referenced only a single application, I assume they submitted only a single application. Would this allow the use of AC5 with any already approved drug or biologic? I speculate that ARTH's application consisted of research saying that the efficacy of a solution of X% of already approved drug M mixed in with AC5, is equivalent to Y% of drug M applied directly.
Regardless of the content of their application, I believe that the important point for investors is that the FDA has not yet responded to the 510(K) application that we read about on 7/25/2017.
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