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Get Ready for FDA Accepted Predetermined Change Control Plans!

Written by Mark Swanson, Partner


On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Industry has the next 90 days to comment on this draft (due the day before Independence Day). This guidance goes across all 3 centers at FDA (CDRH, CBER & CDER), so you can understand there is much interest in guidance that goes across all of the healthcare sciences.

This guidance is focused on the Artificial Intelligence (AI) subset known as Machine Learning (ML) which the FDA will reference as machine learning-enabled device software functions (ML-DSFs). The FDA has recognized that the development of ML-DSFs is an iterative process, meaning that it will be necessary to make rapid step changes as part of the life-cycle of these products. As always, a primary consideration is how to maintain the safety and effectiveness of the product while recognizing the need to support these changes.


In this draft document, the agency provides specific recommendations for the information to include in a Predetermined Change Control Plan (PCCP) that is to be included in the marketing submission for the ML-DSFs. The PCCP will be reviewed as part of the submission, and this is intended to ensure the continued safety and effectiveness of the device without the need for additional marketing submissions to implement each modification described in the PCCP. Yes, you read that correctly...you may be able to make a change without a new submission.


Starting in 2020 and going through October 2022, the US government and specifically the FDA have continued to work on ways to incorporate the information in this current thinking to support the continued development of ML-DSFs. In addition, the Food and Drug Omnibus Reform Act of 2022 (FDORA) provided FDA with express authority to approve or clear PCCPs for devices requiring premarket approval or premarket notification. While this is still a draft guidance, this document clearly represents current thinking and is a leap forward in understanding the applications moving forward.


As with any guidance document, you can begin using them now in your approach. If you are considering developing ML-DSFs, contact QRx at Contact@QRxPartners.com or 833-779-7278 for assistance in developing your PCCP and getting your products on the market.

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