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

In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The discussion kicks off with a critical evaluation of the A-list, B-list, and under construction categories, analyzing the agency's timeline commitments and the practical realities behind how regulatory priorities are established and executed.

The conversation explores specific topics featured on the lists, ranging from AI-enabled device software functions and predetermined change control plans (PCCPs) to more traditional products like respirators and menstrual devices. Dr. Drues shares his perspective on the distinction between wellness devices and those intended for medical purposes, emphasizing the importance of reading between the lines of regulatory text.

Finally, the dialogue delves into broader structural questions surrounding FDA transparency, resource allocation, and how medical device professionals can effectively engage with the agency during the public comment period. Listeners are provided with practical insights on navigating evolving regulatory expectations and submitting comments before the November 30 deadline.

Takeaways

• Monitor the Guidance Lists: Review the CDRH A-list and B-list priorities early to align your R&D and regulatory submission timelines with upcoming FDA expectations.
• Understand Regulatory Intent: Recognize that placement on the A-list reflects CDRH's stated intent rather than a hard guarantee, meaning manufacturers must build flexibility into their regulatory strategies.
• Distinguish Medical Purpose from Wellness: When reviewing product codes and guidance, carefully evaluate how the FDA defines medical intended use versus general wellness to avoid unexpected classification hurdles.
• Participate in Public Comments: Take advantage of the public comment window open until November 30 to provide actionable data and feedback on guidance priorities that impact your specific device portfolio.

References

• CDRH Guidance Document Database: The primary repository for published FDA draft and final guidance documents.
• Etienne Nichols on LinkedIn: Connect with host Etienne Nichols for ongoing medical device discussions and industry updates atEtienne Nichols' LinkedIn.

Sponsors

This episode is brought to you by Greenlight Guru. Navigating complex regulatory landscapes like the FDA's fiscal year priorities requires a robust quality management system and efficient data management. Greenlight Guru's industry-leading Quality Management System (QMS) and Electronic Data Capture (EDC) solutions are built specifically for the medical device industry, helping you bring life-changing products to market faster and with total compliance confidence. Visit Greenlight Guru to streamline your design controls, risk management, and clinical data workflows today.

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