Episode 295

CDRH Proposed Guidance for FY 2023

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.

Today’s conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.

In this episode, you’ll hear what Mike has to say about what’s on the FDA’s A-list and B-list for the fiscal year 2023, what isn’t on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines.

Some of the highlights of this episode include:

What the CDRH proposed guidelines for fiscal year 2023 are about and why it’s important to think about them
Things that stick out on the FDA’s A-list of guidelines
Items that are surprising or exciting on the A-list
What is on the FDA’s B-list of guidelines
What’s missing from the A-list or the B-list
How collective wisdom is shared across various organizations
Whether the FDA should be giving guidance to help companies get products to market
The difference between draft guidance and final guidance
Identifying changes between versions of guidelines
Whether you have to do something if it’s in the guidelines

Memorable quotes from Mike Drues:

“Not to be too arrogant here, but I’m very proud of the fact many of the things that I’ve done in submissions over the years, whether it’s with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”

“That’s why there’s a guidance document database, so you and I don’t have to memorize such esoteric trivia.”

“It’s really not FDA’s job to help a company bring a product on the market.”

“All guidance, indeed all regulation, is very evolutionary. It’s a work in progress.”