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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.

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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.

Links and Resources:

FDA Guidance Least Burdensome Provisions Draft

New Steps to Facilitate Beneficial Medical Device Innovation - FDA

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More - RAPS

FDA medical device proposal may skirt the law: legal experts - Reuters

Mike Drues on LinkedIn

Vascular Sciences

Jon Speer on LinkedIn

Greenlight Guru

Quotes:

The alternative path is being marketed as a new fast-track path... that is obviously going to capture people’s attention. But is there anything new about it?” -Mike

The new path puts a greater emphasis on technical standards... it’s similar to what we’ve been accustomed to many years.” -Jon

This is exactly the abbreviated 510(k). There is absolutely nothing new here.” -Mike


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