Overview
The FDA’s Total Product Life Cycle, or TPLC, approach to the oversight of AI in medical devices is discussed in their January 2025 Lifecycle Draft Guidance. The FDA’s TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by taking into account all available information on safety and effectiveness.
FDA will take a risk-based approach to specific testing needs and applicable recommendations to support marketing submissions for AI-enabled devices. A “device software function” is a software function that meets the device definition in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). AI-enabled devices are devices that include one or more AI-enabled Device Software Functions (AI-DSFs). This guidance are intended to assist with device development and lifecycle management of AI-enabled devices, which should help support the safety and effectiveness of these devices. This guidance provides both 1) specific recommendations on the information and documentation to support a marketing submission for an AI-enabled device, as well as 2) recommendations for the design, development, deployment, maintenance of AI devices, including performance management. This guidance also includes FDA’s current thinking on strategies to address transparency and bias throughout the TPLC of AI-enabled devices. These should be incorporated from device design through decommission to help design transparency and the control of bias into the device and ensure its safety and effectiveness. This webinar will provides recommendations on the documentation that should be included in marketing submissions (510(k)s, De Novos, PMAs, HDEs, BLAs) to support FDA’s review of devices that include AI-DSFs.
Why Should You Attend
This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC) approach to the oversight of medical devices, including artificial intelligence (AI)-enabled devices. Some recent efforts include developing guiding principles for good machine learning practice (GMLP) and transparency for machine learning-enabled devices. This is to help promote safe, effective, and high-quality machine learning models. They have held a public workshop on fostering a patient-centered approach to AI-enabled devices, including discussions of device transparency for users.
This webinar will examine the new January 2025 Draft Guidance on "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations" . This Guidance provides total lifecycle management and marketing submission recommendations consistent with a TPLC approach for AI-enabled devices. This guidance provides recommendations on the contents of marketing submissions (510(k), De Novos, PMAs) for devices that include AI-enabled device software functions including documentation and information that will support FDA’s review.
Webinar Takeaway
- The New 2025 Draft Guidance For AI-Enabled Medical Devices
- What is Risk-Based?
- Total Product Life Cycle (TPLC) Approach to Medical Devicess
- Specific FDA requirements for SI-DSF Submissions
- FDA Rrecommendations for the design, development, deployment, maintenance of AI devicesContents of marketing submissions (510(k)s, De Novos, PMAs, HDEs, BLAs) w/ AI-DSFs.
- TPLC Considerations Pre- and Post-market and in Submissions/FDA Reviews
Who Will Benefit
- Senior management in Devices, AI Technology
- Marketing
- QA
- RA
- Engineering
- R&D
- Operations
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
