To be clear, the company is not told of any news until 90 days, at which time FDA has to inform the company if review gets put on hold, pending specific requested information. If no additional info needed, the FDA could, as of 90 days, grant approval of the device. However, it does not mean that approval has to be accepted at 90 days. It could take up to 180 days. Take home point: only if bad news, would company be told so, on the 90 day. No news on the 90 th day is good news, but doesnt mean device has to be approved at 90 days.