Medtech Matters
The Alternative Summary Reporting Program
- Autor: Vários
- Narrador: Vários
- Editor: Podcast
- Duración: 0:25:54
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Sinopsis
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including:What is the alternative summary reporting program?Was the reporting of the “discovery” of this program fair or was it media hype?Why did the FDA recently cancel the program?What will medical device manufacturers be required to do now?What is the ultimate result of this ban/change?What are the takeaways and/or lessons to be learned?Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. 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 upc