Podcast appearances · Radar

Mike Drues

Mike Drues, Ph.D., is president of Vascular Sciences, a medtech regulatory consulting firm, and a regular guest expert on medtech podcasts including Mike on Medtech.

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APPEARANCES

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PODCASTS

Sep 11, 2026

Medtech Matters

Medtech Matters

A Preview of MDUFA VI: Changes and Highlights, Part 2

Sep 11 · 51m

Sean FenskeHOST

7:28

But that's just, that's a complete guess.

Mike DruesGUEST

7:31

Yeah, it's a good guess, John.

Mike DruesGUEST

7:32

It's a great start.

Mike DruesGUEST

7:34

So let me just slightly modify a little bit of what you just said here.

Mike DruesGUEST

7:38

First of all, major deficiency letter is a formal communication during the substantive review of a PMA or an HDE device.

Mike DruesGUEST

7:49

So this is not for 510 s or de novos, although it is sort of akin, substantial equivalence, if you will, to a AIR, an additional information request.

Mike DruesGUEST

8:01

that companies unfortunately often get after submitting a 510K or de novo.

8 MINS LATER

Sean FenskeHOST

16:17

Save your spot today at MPOsummit.com. That's MPOsummit.com.