RE: Peoples thoughts24 Mar 2024 13:33
My view is that, it’s not a dream or guess anymore. The NICE assessment/ recommendation of ROCA is just the beginning. In terms of CIC-Score, FDA’s initial assessment was that it’s ‘first in class' position and have deep clinical evidence for polygenic risk assessment of CHD’. Hence, asked to submit under De Novo pathway.
As you may know, The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
Bright days ahead in my view 🙌
GLA