GREY:TSTIF - Post by User
Comment by
Drrwongon Aug 27, 2017 6:33pm
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Post# 26626507
RE:RE:RE:RE:Bloomberg interview
RE:RE:RE:RE:Bloomberg interviewI actually agree with SPDMGR's point on the importance of the manufacturers' IFU.
But that is exactly why TSO3 is doing joint submission with the manufacturers on the duodenoscopes, rather than trying to get a broad cliam like the colonoscopes. As you recall, RR said in the 1Q17 call that their portion of their testing were completed, but they have to wait for the manufacturers to complete their side of the testing before submitting, which happened just recently. So once FDA approves the new submissions, it will be incorported into the IFUs for these two scopes (will include durability data). In the future, given the new FDA regulations (as pointed out elsewhere in the blog), all new scopes' IFU will include sterilization methodology and data.