Premarket Pathways News Today

It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value. In my mind, the data can simply become what they claim to be. But i...

FDA’s regulatory classification for Thoracolumbosacral pedicle screw system. Data from the 510k files seem like they would be accurate. Similar to UDI database, 510k database is based on input initially from companies. eSTAR system asks whether device is combination product.

FDA recently issued its new final guidance concerning the appropriate pathway for review of drug-device combination products, Principles of Premarket Pathways for Combination Products...

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional...

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any...