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 The discussion paper describes a risk-based approach that differs significantly from the FDA's initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.
The Food and Drug Administration recently issued draft guidance, providing its initial thoughts on regulatory requirements for devices manufactured using additive manufacturing (AM), a category that includes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 Federal Trade Commission – in coordination with the Food and Drug Administration, the Department of Health and Human Services' Office for Civil Rights and the Office of the National Coordinator for Health Information Technology – has developed an interactive web-based tool to help mobile health app developers to understand what federal laws and regulations might apply to their apps.