FDA’s Refuse to Accept Policy for 510(k)s
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 look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:Please start with an explanation of the FDA’s review process. What happens after the agency receives a submission?This...
