2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul of medical device regulations in Europe. The EU MDR is set to come into effect in May 2020, and the industry is also facing impactful changes across the pond.
At the end of 2018, the FDA announced several upcoming changes to the way medical devices are approved in the United States. With no signs that these changes will be delayed, it’s just a matter of time before the FDA provides updated guidelines and requirements.
In this White Paper, we will discuss three expected changes to the FDA medical device approval process. In particular, we will discuss:
1) the proposed revision to the 510(k) process;
2) the proposed new rules on the de novo pathway; and
3) the changes in the way e-health technologies will be evaluated
Download your copy of the White Paper by filling out the form below.