> it simply issues (with a refund of the permit processing fees) if the deadline passes. We're a medical device company with Breakthrough Device status, and it

> it simply issues (with a refund of the permit processing fees) if the deadline passes. We're a medical device company with Breakthrough Device status, and it works largely like this. Whenever we submit, FDA has 30 days to reach a decision from time of receipt, and if they don't decide, we automatically get approval. Really helps with keeping up momentum!