Zdrowie i gospodarka · 15/12/2017

FDA Releases Draft Guidance on Least Burdensome Provisions for Medical Device Regulation

The Food and Drug Administration (FDA) has released a draft guidance document outlining the concept and principles of the 'least burdensome provisions' approach to medical device regulation. This approach aims to balance the need for regulatory clarity with the goal of minimizing unnecessary burdens on industry and facilitating the marketing of new products.