Artificial Intelligence: Engaging FDA

December 12, 2023

Nathan Downing presented on artificial intelligence in medical products and strategies for partnering with FDA at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you do not have time to watch the session recording, please read below for some highlights on this topic.

FDA continues to see an increase in the amount of medical products incorporating artificial intelligence and machine learning, especially in medical devices. This allows FDA to familiarize itself with the technology, creating more predictability for paths to get products on the market. However, FDA regulations have not caught up with this advanced technology. As a result, those in industry seeking to place medical products that incorporate artificial intelligence on the market need to have a plan in place for engaging FDA.

Considerations for Market Authorization

Given the unique nature of medical products that incorporate artificial intelligence, there are certain considerations companies should account for on their path to clearance or approval.

Does the medical device require 510(k) clearance? If so, it is important to accurately assess any predicate devices. It is possible, depending on what exactly the role of the artificial intelligence component of the medical product is, that a predicate does not exist. Similarly, the indication must be closely scrutinized to ensure it matches the capability of the artificial intelligence in the medical product.

Does the medical device require approval under a PMA? If this is the required pathway, make sure to understand the required testing or if there are unknowns given the artificial intelligence element of the device. Be sure to have an adequate change control plan. The nature of artificial intelligence can lead to many changes to the device post-market, and misunderstanding the regulatory actions required can lead to surprises in costs and timing.

Obviously, if any pre-market authorization for an artificial intelligence-enabled medical product is required, FDA will be involved. Identifying any roadblocks is key for efficiency and predictability.

Create and Execute a Plan to Communication with FDA

As a company, you will need to identify a plan to educate FDA on your medical product and the accompanying artificial intelligence components. A good start may be an informational pre-submission where FDA will be educated on your product and the technology supporting it. This provides an opportunity to tell your story, get in front of the division that will review your product, and begin procedural discussions on the path forward. Although FDA has increasing touchpoints with artificial intelligence, your specific device may have nuances that will greatly benefit from this initial meeting.

Pre-submissions may also be warranted regarding the classification of the product or to help adjudicate whether identified predicates are proper. Given the newness of artificial intelligence, it may help to discuss testing plans to ensure they will provide the data FDA require. Additionally, while the medical product is under review, you may regularly reach out in an informal manner to offer any information FDA may need, such as demonstrations on how the artificial intelligence operates.

Once a company has created a plan to communicate with FDA, execution is key to benefitting from those communications. Consider whether your understanding of the technology is mature enough to communicate to FDA in an informational setting. If you are seeking feedback, do you plan on making additional changes that would make any FDA feedback moot? You should know what you know, and what you do not know. Having a strong plan in place to make sure the entire team understands the story behind the product is key to helping FDA weigh in on any knowledge gaps. The newness of artificial intelligence offers great potential for patients and industry, but also many unknowns. Smartly partnering with FDA is one way to mitigate as much risk as possible.

Successful Partnership

The key to a successful partnership with FDA is to truly understand your medical product and work with professionals who understand FDA. Benefitting patients from the potential of artificial intelligence is a goal shared by both industry and FDA. Taking advantage of that shared goal will only lead to better treatments for patients and more predictable pathways for those in industry.

Gardner Law has extensive experience in communicating with FDA on a variety of issues and medical products. If you are drafting a plan to communicate with FDA, the team at Gardner Law can help.

Learn more about this topic by watching Nathan Downing’s session at Gardner Law’s Mastering Tomorrow’s Healthcare Tech event.