AI for FDA 510(k) Submission Preparation
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes
Webinar Id:
55653
More Trainings by this Expert
Overview:
The artificial intelligence technologies granted FDA marketing authorization and cleared by the Agency are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
However, the FDA is now focusing on 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 allowing 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, without requiring frequent updates or submissions.
This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the Agency would 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" (PCCP). It will also address using AI to assist in preparing the 510(k) submission documentation for such applications.
Why you should Attend:
The US FDA has defined the steps needed for the regulatory framework for the development of safe and effective medical devices that use advanced artificial intelligence / machine learning algorithms. Artificial intelligence algorithms are software that can learn from and act on data.
The authorization of these technologies was 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. Since AI changes over time, how will the Agency control these changes without requiring newmarketing submissions. AI software validation has some new requirements as well. Industry can use AI to safely speed up the preparation and documentation of company product 510(k) submissions to the Agency as well, which will also be considered in this webinar.
Areas Covered in Session:
- The FDA's AI "Framework" for AI in Medical Devices
- Roles of Verification and Validation
- IEC 62304 and an FDA Software Guidance
- FDA AI device 510(k) submission requirements
- A Typical Software V&V Protocol / Test Report; "Black" and "White" box
- "Locked" vs ML algorithms
- Predetermined Change Control in AI
- Expected Regulatory 510(k) Submission Deliverables - Use of AI
- The Future of AI in Medical Devices
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated AI medical device R&D and production activities and documentation requirements, as currently anticipated by the US FDA. This information applies to personnel / companies in the Medical Device and some Combination products fields. The employees who will benefit include:
- Software engineering
- Senior management
- Regulatory Affairs
- Quality Assurance / QAE
- Production
- Engineering, R&D, and software development and testing teams
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and productioin / test equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless systems, or other regulated medical products / CGMP, ISO QMS, and submission activities.
Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
