Tag Archives: regulations

Do You Know Your de novo?

By Jill | Medical Devices, , ,

In July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. The act makes major changes in the way certain medical devices are considered during pre-market review. The complex law made changes to the de novo reclassification process, based on the Latin term de novo which means “afresh” or […]

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