Overview
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
However, the FDA is looking beyond these elemental devices, to those capable of true AI, - machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms. Adaptive algorithms can learn from new user data presented to the algorithm through real-world use. The FDA is exploring a framework to allow modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device (SaMD) is maintained.
This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review. They include the algorithm’s performance, the added concerns for AI / ML software verification and Validation, the manufacturer’s plan for modifications and the ability of the manufacturer to manage and control risks of the modifications, including the software’s "predetermined change control plan", throughout the device's total product lifecycle.
Why Should You Attend
The US FDA has announced a Draft Guidance addressing steps toward a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence / machine learning algorithms, throughout their lifecycle. Artificial intelligence algorithms are software that can learn from and act on data.
These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. The recent authorization of devices using these technologies is a harbinger of progress that the FDA expects to see as more medical devices incorporate advanced artificial intelligence algorithms to improve their performance and safety throughout the TPLC (Total Product Lifecycle) of these devices. The Agency plans to apply their current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices.
Webinar Takeaway
- Roles of Verification and Validation
- The FDA's AI TPLC Management Draft Guidance
- FDA AI device submission requirements
- A Typical Software V&V Protocol / Test Report; "Black" and "White" box
- Predetermined Change Control in AI
- Expected Regulatory Submission Deliverables
- The Future of AI in Medical Devices
Who Will Benefit
- Software Engineering
- Senior Management
- Regulatory Affairs
- Quality Assurance / QAE
- Production
- Engineering
- R&D
- Software Development and Testing Teams
Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is a leading FDA compliance and regulatory affairs consultant with over 41 years of experience in FDA-regulated industries and 27 years as Principal of J. E. Lincoln and Associates LLC. He is recognized globally for his expertise in cGMP compliance, quality assurance, and medical device validation.
Throughout his career, John has partnered with pharmaceutical, biotechnology, and medical device companies — from startups to Fortune 100 organizations — across the U.S., Canada, Mexico, Europe (France, Germany, Sweden), and Asia (China, Taiwan).
His consulting specialties include:
- FDA Quality System Regulation (QSR) compliance and QMS remediation
- Process, product, and software validation (including 21 CFR Part 11 systems)
- ISO 13485 and ISO 14971 risk management implementation
- Design Control, Design History File (DHF), and Technical File development
- Regulatory submissions, including FDA 510(k) filings and responses to FDA audit observations
John has held leadership roles in Manufacturing Engineering, Quality Assurance, Quality Engineering, Regulatory Affairs, and R&D, progressing to Director and Vice President levels.
As a recognized FDA industry expert and speaker, he has:
- Authored peer-reviewed journal articles and five chapters in the RAPS textbook on validation
- Delivered global workshops, seminars, and webinars on FDA cGMP, validation, and risk management
- Helped hundreds of organizations achieve FDA and ISO compliance through practical, hands-on training
