Ann: FDA Strategy and Regulatory Update, page-40

I'm hoping its in 21 days mate but I am pretty sure you're reading the guideline wrong. The start of the 'Substantive Review' process is the 16th day, not the 60th.

"Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days."

They don't say it starts on day 60, it ends by day 60.

Therefore:
- Acceptance - Days 1-15.
- Substantive Review - Days 16-60 (which we just begun. Therefore, considering the 7 days, we are at day 23 with another 37 to go).
- Final Decision - Days 61-90.
Total = potentially 67 days to go.

As I said, I do hope I am wrong. I really do. I just thought it was worth mentioning in case anyone gets upset if we don't hear news for quite a while...