The FDA has historically provided inspection guides across a range of critical areas that affect medical devices, including Quality Systems, Electromagnetic Compatibility Aspects of Medical Device Quality Systems, Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices, Mammography Quality Standards Act Auditor’s Guide, and guidelines for Medical Device Manufacturers. Although the FDA hasn’t yet issued an inspection guide specifically focused on cybersecurity, the precedent set by these other areas suggests that such guidance may be on the horizon, especially as the need for cybersecurity regulations in healthcare continue to escalate. Similarly, FDA has publicly stated since the passage of the 2023 Omnibus which included amendments to the Food, Drug and Cosmetic Act (FD&C Act) such as 524B, focused entirely on cybersecurity, that their early focus would be on premarket enforcement. They indicated at that time that postmarket would follow eventually, but premarket was a more powerful tool for the agency because of the challenges with postmarket enforcement and the timeliness and effectiveness.

Understanding FDA Inspection Guides for Medical Devices

What is the importance of an inspection guide? An inspection guide outlines expectations for compliance within a specified domain, aiming to standardize practices and uphold safety and quality standards across the industry. However, these guides are non-binding, meaning manufacturers can meet compliance requirements through alternative methods, as long as they still satisfy the underlying statutes and regulations. The inspection guide is intended for both the FDA inspector/investigator and to ensure predictability for the manufacturer in what to expect during an inspection.

For quality systems, for instance, FDA’s guide highlights the importance of robust controls in ensuring product safety and effectiveness, and directs the inspector on which areas of the quality system to assess to demonstrate compliance. Similarly, for cybersecurity, any future guidance may require evidence of robust security controls throughout a device’s lifecycle, from design to deployment and monitoring. Such a guide would likely specify key compliance areas, inspection protocols, and documentation expectations for cybersecurity practices, aimed at helping manufacturers prepare their devices for current and emerging cyber threats.

Timeline Challenges: Why Cybersecurity Guides May Take Time

The process of issuing inspection guides is comprehensive and can be lengthy. Because cybersecurity is a rapidly evolving field, the FDA may be taking extra care to ensure any inspection guide will reflect the state of the art in cybersecurity, reflect training for inspectors, and remain relevant as new threats and technologies emerge.

What Device Manufacturers Can Do Now

While an official inspection guide focused on cybersecurity may still be in development, medical device quality and regulatory teams should remain proactive. Here are steps to take now to prepare for the potential release of this guide:

1. Stay Current with FDA Announcements: Regularly monitor FDA communications for any updates on inspection guides, as the FDA often provides preliminary information before a new guide is released.
2. Build a Cybersecurity-First Compliance Strategy: Begin adopting cybersecurity best practices based on existing FDA cybersecurity guidance documents. This can include implementing robust risk management processes, ongoing monitoring, and incident response planning. Designing new devices securely from the start will benefit in many ways. Evaluating the cybersecurity risks of on-market devices will protect you from postmarket incidents and demonstrate that you are managing the postmarket cybersecurity of those products as well, even if they are not directly impacted by 524B as they were cleared or approved prior to its enactment.
3. Prepare Your Quality Systems: FDA’s Quality System Regulation (QSR) already mandates certain requirements that can overlap with cybersecurity controls. By strengthening quality systems now, especially in areas like design controls and corrective actions, manufacturers can stay a step ahead of postmarket problems and questions raised by inspectors.
4. Work with Regulatory Experts: Collaborate with regulatory specialists who understand the intricacies of FDA compliance and cybersecurity. They can offer valuable insights to ensure your quality and cybersecurity systems align with FDA expectations and can withstand future scrutiny.

Quality and regulatory leads will not only be ready for FDA inspections but also play a vital role in safeguarding patient health and maintaining trust in healthcare technology. Ensure your organization is prepared for a potential cybersecurity inspection guide.

Looking for support meeting FDA cybersecurity requirements to secure medical devices by design and improve patient safety? Connect with Medcrypt for the ways we can help your organization. Email us at info@medcrypt.com and visit our website.