In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing the conversation of guidance documents that are expected to gain the attention of the agency in 2027. While some of the guidance topics outlined may not see an official release for a few years, several will come into effect in the next year. Are these the highest priority areas that require guidance? Has FDA missed out by not including certain focus areas? During this conversation, the following questions are addressed:

Can you provide a quick review of part 1 of this discussion?
What can we expect with regard to guidance in 2027 from FDA?
What’s on FDA’s A-List of Guidance Topics for 2027?
What’s on the B-List of Guidance Topics for 2027?
What’s on the “Under Construction List” of Guidance Topics for 2027?
How do topics get on these lists?
What topics are NOT on these lists but probably should be?
Do you have suggestions for FDA regarding guidance documents?
Should FDA even be in the business of writing guidance documents? Is that really their job?
What else is important?
What are the takeaways?

Listen to this discussion and see what you think of the upcoming FDA guidance. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, plea

For more medtech news and information, visit https://www.mpomag.com.

An Early Look at FDA’s Guidance Focus for 2027, Part 2

Medtech Matters

An Early Look at FDA’s Guidance Focus for 2027, Part 2