100% disagree! Since the new rule established special controls that did not exist for the previous ILX Class III classification, and this happened during the pendency of the 510K, it would require evaluation according to the new rules for that classification. If FDA had not made a decision on the 510K by Oct 13 (70 days after the submission; this is the likely case, as they know that the new rule was imminent), they cannot simply place it in the new SWT code. They will have to evaluate if the application meets the new special control requirements. I have communicated with the FDA about this - as I was worried that a new 510K will be needed - and have been told that in such cases in general a fresh 510K is not needed and the FDA will work with the applicant to complete the process. If anything one should expect a small delay compared to nominal times, but I expect not too much, as the reviewers are fresh with the just-completed reclassfication. Note though, that the 90 days is the goal and by 100 days they would issue a missed decision letter - that is 100 days without any additional requests from the FDA. I am of the view that the FDA would be in touch with Bielcorp on this, as the device category changed during the review. Since the special controls were already laid out in the proposed rule and Bielcorp was aware of it and they used an experienced law firm, there would not have been much AI needed. My own expectation is that a decison may be forthcoming in the Dec-Jan time frame. Hopefully Dec. Let us not set a specific date and expect a decision from the FDA by that date - it doesnt happen. The likelihood of a decison keeps getting better as we approach and pass that date.
