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[January 2024 Issue] FDA Issues New Guidance on RIEs, Premarket Cybersecurity Considerations for Device Quality Systems + Warning Letter Breakdown

We dive into the FDA's updated RIE guidance, another covering premarket cybersecurity considerations for device quality systems, and dissect a CGMP warning letter.

Welcome to Insider issue #21.

And a very warm welcome to the 385 new life science professionals who joined last month. If you haven’t already graduated to a paid subscription to unlock issues like this one, you can do so here.

Our pharma segment explores the FDA's latest guidance on using remote interactive evaluations (RIEs) in a post-pandemic world. This new draft guidance, released on October 25, represents a pivotal shift in the FDA's approach, building upon the learnings and successes from the COVID-19 pandemic. It covers a spectrum of inspections, including preapproval, prelicense, and postapproval, marking a significant evolution in the FDA's inspection methodology.

We dissect the nuances of this guidance, from the voluntary nature of RIEs to the technological and compliance expectations set forth by the FDA. Our breakdown offers actionable insights for pharmaceutical companies to effectively adapt to this new regulatory environment, emphasizing the importance of being technologically equipped and procedurally ready for these remote evaluations.

Our device segment analyzes the FDA's finalized guidance on premarket cybersecurity considerations for medical devices, issued on September 27, 2023. This comprehensive guidance underscores the growing significance of cybersecurity in the medical device realm, particularly for AI/ML-enabled and cloud-based devices. We delve into the critical components of this guidance, from the Secure Product Development Framework to the nuances of managing cybersecurity risks. Our focused review provides medical device manufacturers with a roadmap to align with these new requirements, highlighting key areas such as cybersecurity risk management, software bill of materials, and postmarket monitoring.

Lastly, we turn our attention to a recent FDA warning letter issued to a pharmaceutical company over CGMP deviations. We parse the contents of the warning letter, providing a comprehensive analysis of the deviations noted and the FDA's recommendations.

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The FDA Group