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• The difference between draft guidance and final guidance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.”

Links:

Mike Drues LinkedIn

FDA Website: CDRH Proposed Guidance’s for Fiscal Year 2023

RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)

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