FDA Pre-Sub Best Practices
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 pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including:Can you please give a brief overview of what the FDA’s pre-sub program is?Is the pre-sub only for certain types of devices or when using certain regulatory pathways or is it available to all devi...
