# #476: Part 2: FDA Guidance: What We Should Expect in 2027

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-10-15
- Length: 52m
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-10-15-476-part-2-fda-guidance-what-we-should-expect-in-2027

## Summary

Regulatory consultant Michael Drues, Ph.D., joins host Etienne Nichols to analyze the FDA's Center for Devices and Radiological Health (CDRH) guidance priorities for fiscal year 2027, covering the A-list, B-list, and under-construction categories. Drues critiques the agency's use of vague language like "intends to publish" and "resources permit," noting that only 63% of previous guidance documents were actually released, and questions why B-list items like cybersecurity are prioritized over A-list topics. The discussion highlights the distinction between wellness devices and those with medical purposes, the iterative nature of regulation, and the potential risks of relying on AI for both submission writing and review.

## Outline

1. Introduction: FDA FY2027 Guidance Priorities and List Categories
2. Critique of FDA Language: 'Intends to Publish' and Resource Constraints
3. Analysis of the A-List: AI, Respirators, and Surgical Robots
4. B-List Deep Dive: Pulse Oximeters, Cybersecurity, and Q-Sub Programs
5. Under-Construction List: Predicate Selection and Thermal Effects
6. The Role of AI in Submissions and FDA Review Processes
7. How Guidance Documents Are Created and What's Missing
8. Suggestions for Improving the Guidance Document Database
9. Should the FDA Write Technical Guidance? The 'Blind Leading the Blind' Argument

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- CDRH (company)
- MedUCA (other)
- 510K (other)
- PCCP (other)
- AI (other)

## Citing this page

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