The Special 510k Program
Medtech Matters - En podkast av Medical Product Outsourcing - Tirsdager
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:What is the Special 510(k) program and how does it diff...
