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The FDA is classifying pancreatic drainage stent and delivery systems as Class II with special controls, but will still require premarket notification before distribution. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two branches in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, under an experimental program announced May 1. Read More
The U.S. Food and Drug Administration is proposing a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More