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Validity : 25th Feb'24 to 06th Mar'24
Understand what a 510(k) is and the submission process to the FDA.
Understand the regulatory issue preventing ML products from learning post 510(k) clearance. Understand the FDA’s proposed solution.
Understand the contents of an ML 510(k) submission based on the examination of many cleared ML 510(k)’s
We will explain what a 510(k) is and explain the other FDA regulatory pathways. We will discuss how software can be considered a device by the FDA.
The procedure to obtain a 510(k) will be explained. The contents of the submission to the FDA will be explained.
The very confusing concepts of “predicate device’ and “substantial equivalence” will be explained.
How to find an acceptable predicate device will be explained
FDA clears the final validated version of the software and requires a new 510(k) submission if “substantial changes” are made post-release. We will explain how to evaluate changes to software and hardware.
The requirement for a new 510(k) submission for a substantial change leads to the regulatory difficulty Machine Learning products find themselves. An ML product is designed to learn and update post-approval and release. The updated ML algorithm is no longer the approved validated product. Thus the changes probably necessitate a new 510(k) submission for each update.
FDA recognizes this problem and has proposed a methodology to satisfy the regulations. We will discuss this proposed FDA solution which will become a Guidance this year.
In the meantime, FDA has approved “locked” ML products. We will discuss what that is and, based on a review of the submissions of cleared ML products, what the FDA wants to see in an ML 510(k) submission so that you can get your ML product cleared now.
This webinar is not a programming course but is an explanation of the regulatory process.
Attendees are expected to have a basic knowledge of FDA regulations and machine learning concepts.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.