How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices

doctor holding tablet AI biomedical algorithmIn the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that could result in entirely different products doing very different things than were initially approved.

If AI-induced changes result in an un-approved use, manufacturers could lose precious pre-emption immunity from liability gained through FDA approval, especially if the device later becomes defective.

Currently, federal law generally preempts personal-injury suits for FDA approved medical devices. Major changes to products, including to algorithms and software, trigger FDA review and necessitate re-approval. 

This poses particular concern because it is incredibly difficult to estimate at what point machine learning will result in a new product or exceed the scope of approved use.  The FDA recognizes this issue, stating in its discussion paper: “The traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimize performance in real-time to continuously improve healthcare for patients.  The highly iterative, autonomous, and adaptive nature of these tools requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards.”

The FDA is currently seeking comments on a regulatory framework for AI-based products which learn and adapt. The Discussion Paper and Request for Feedback can be found here:

Cozen O’Connor’s Product Liability team is available to help medical device manufacturers navigate emerging FDA regulatory issues like this.

About The Author
Posted in FDA

Leave a Reply

Your email address will not be published. Required fields are marked *


Subscribe For Updates


Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
Recent Comments
Cozen O’Connor Blogs