2019 is set to be another interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul of medical device regulations in Europe. 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. In this White Paper, we will discuss three expected changes to the FDA medical device approval process in 2019. 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.