IDL Biotech: 510k path confirmed
On Friday, IDL Biotech announced that it have recieved feedback from the FDA regarding its pre-submission request. It is now confimed IDL will pursue the 510k route in order to reach approval for UBC Rapid in the US market. We have a positive view on the news, as IDL has to show that UBC Rapid is substantially equivalent to a predicate device already approved by the FDA (most probably NMP22).