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Episode 56  |  29:01 min

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56  |  29:01 min  |  11.07.2019

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

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This is a podcast episode titled, Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway. The summary for this episode is: This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you. Some of the highlights of the show include: ● What the new draft is about and how long this fast track has really been around. ● Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office. ● The FDA’s revised definition of “least burdensome.” ● Why, despite increased marketing and hype, the “new” path is not really new at all. ● What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier. ● Some questions to ask yourself if you want to know if you are working on something new or novel.
This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you. Some of the highlights of the show include: ● What the new draft is about and how long this fast track has really been around. ● Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office. ● The FDA’s revised definition of “least burdensome.” ● Why, despite increased marketing and hype, the “new” path is not really new at all. ● What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier. ● Some questions to ask yourself if you want to know if you are working on something new or novel.

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