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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In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore how manufacturers can navigate them effectively. The discussion covers the distinction between regulations in the Code of Federal Regulations and agency guidance, highlighting why a rigid, literal interpretation can be dangerous for product development.

The conversation examines the practical realities of using guidance documents as tactical tools and highlights the importance of proactive engagement with the agency. Mike shares valuable insights on challenging assumptions, understanding the shades of gray in regulatory compliance, and the strategic advantages of addressing deviations early through the pre-submission process. They also touch upon the limitations of the FDA guidance database and why revision history matters.

As part one of a two-part series, this episode lays the critical foundation for understanding how guidance shapes medical device development. Listeners will gain a fresh perspective on interacting with the FDA, moving beyond compliance checkboxes to build robust, defensible regulatory strategies. Stay tuned for part two, where the discussion shifts specifically to the fiscal year 2027 guidance list.

Takeaways

• Understand the distinction: Recognize that regulations in the CFR carry legal weight originating from Congress, whereas guidance documents represent FDA's current administrative or technical thinking and are technically non-binding.
• Avoid absolutism: Do not treat guidance documents as immutable laws; manufacturers can propose alternative approaches if they satisfy statutory and regulatory requirements.
• Leverage the pre-sub process: If your device strategy diverges from a published guidance document, address the deviation proactively during a pre-submission meeting rather than waiting for a rejection on your final submission.
• Look beyond the database: Use multiple search avenues—including broader web searches and direct inquiries through OICE/Dice—to track updates, historical revisions, and guidance documents currently in development.

References

• 21 CFR Part 10.115 - FDA’s Good Guidance Practices regulation outlining how guidance documents are developed and utilized.
• CDRH Guidance Document Database - The primary repository for current FDA medical device guidance documents.
• Etienne Nichols' LinkedIn - Connect with Etienne Nichols for more MedTech discussions and insights.

Sponsors

Greenlight Guru provides an industry-leading MedTech quality management solution that integrates both powerful QMS and EDC software onto a single platform.

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We want to hear from you! What topics would you like us to cover in future episodes, or how are you navigating FDA guidance updates in your current projects? Send your thoughts, feedback, and topic suggestions directly to podcast@greenlight.guru, and our team will provide a personalized response. Don't forget to leave us a review!

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Nikhil Mangale, Vice President of Quality at Kapstone Medical, to discuss the real-world impact of the FDA's Quality Management System Regulation (QMSR). Seven months post-implementation, the industry is seeing actual inspection data that shifts the focus away from superficial documentation updates and directly onto core quality system operations.

Nikhil breaks down the top five areas where the FDA is issuing citations under the new regulation: risk management, supplier controls, complaint handling, Unique Device Identification (UDI), and corrective actions. The discussion highlights how the industry spent years worrying about renaming documents like Design History Files (DHFs) to Design and Development Files (DDFs), yet inspectors are bypassing mere translation projects to evaluate how information flows across living quality processes.

The conversation offers actionable guidance on conducting thorough, multi-layered gap assessments for both active and legacy products. Nikhil provides strategic advice for small companies and startups on prioritizing risk management, handling supplier audit visibility, navigating ISO 13485 alignment, and weighing the benefits of participating in programs like MDSAP.

• Prioritize Risk as a Living Process: Risk management must continuously integrate post-market feedback, complaint data, and nonconformances rather than remaining a static file archived after design release.
• Re-evaluate Supplier Audits for External Scrutiny: Routine supplier audit records are now accessible to FDA inspectors; ensure reports are well-documented, audit schedules are risk-proportionate, and findings are formally resolved.
• Implement a Three-Layer Mapping Strategy: Move beyond surface-level terminology updates (Layer 1) to establish subclause conformity (Layer 2) and verify operational evidence across interrelated processes (Layer 3).
• Maintain Open Design and Development Files (DDF): Unlike legacy DHFs that were closed at commercial launch, DDFs must remain active throughout the product lifecycle to evaluate ongoing design changes.
• Formulate a Defensible Quality Plan: When addressing gaps, document a risk-prioritized, sequential quality plan to show objective evidence of a structured compliance roadmap during an inspection.

• FDA Compliance Program CP 7382.045: The FDA inspection guidance replacing QSIT, organizing surveillance around core QMS areas and specific regulations.
• ISO 13485:2016: The international standard for medical device quality management systems incorporated by reference into the FDA's QMSR.
• Etienne Nichols LinkedIn Profile - Connect with the host of the Global Medical Device Podcast.

We want to hear from you! What challenges are you experiencing with your QMSR implementation or risk management files? Send your feedback, reviews, or topic suggestions directly to podcast@greenlight.guru. We personally review and respond to every message from our listeners!

This episode is brought to you by Greenlight Guru.