In an unusual move, the Food and Drug Administration (FDA) recently published a discussion paper which proposes a new regulatory framework for laboratory-developed tests. The discussion paper describes a risk-based approach that differs significantly from the FDA's initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.
The Food and Drug Administration recently issued draft guidance, providing its initial thoughts on regulatory requirements for devices manufactured using additive manufacturing (AM), a category that includes three-dimensionally printed medical devices. AM enables companies to design and create devices with complex or delicate internal structures more easily.
The Food and Drug Administration has issued draft guidance announcing that it does not intend to enforce compliance with the regulatory controls that apply to software medical device data systems, medical image storage devices or medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.