FDA Prediction, page-27

I read some where the New MDR regs to get the CE mark are more stringent and are almost on par with FDA approvals/grant timelines now.

As MDR have upgraded requirements on clinical trials ,risk management, postmarket surveillance and supplier management. To Improve product quality, reliability and safety.

I took a quick look at the last ten denovo grants and time to reach them. In months below. Although it doesn’t actually mean anything as there in different categories and some therefore take longer but here they are anyway.

8 months
11 months
5 months
5 ½
19
13
9 ½
5
12
11




Not investment advice, do your own research, and consult a licensed adviser