Medtech Matters

In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance. Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferr