The FDA’s Center for Devices and Radiological Health (CDRH) has released a draft guidance on predetermined change control plans for Artificial Intelligence (AI)/Machine Learning (ML)– enabled medical devices.
The guidance proposes a science-based approach to ensure that such devices can be safely and effectively modified, updated, and improved in response to new data. The approach would enable more extensive and rapid modification of Artificial Intelligence & Machine Learning (AI/ML)-enabled devices to learn and adapt to local conditions, increasing the pace of medical device innovation and enabling more personalized medicine.
The FDA is committed to ensuring the safety and effectiveness of AI/ML-enabled devices throughout their lifecycle and will review and agree to the Predetermined Change Control Plan for each device.
The FDA is seeking comments on this draft guidance from stakeholders and intends to issue final guidance as part of its commitment to advancing safe and effective medical device innovations for the benefit of public health.
Our team of experts can provide guidance on developing a predetermined change control plan that meets the FDA’s requirements and facilitates safe and effective modifications to AI/ML-enabled medical devices.
With our in-depth knowledge of the regulatory landscape, we can help medical device companies stay ahead of regulatory changes and ensure compliance with FDA guidelines. Our goal is to help our clients bring safe and effective medical devices to market quickly and efficiently while maintaining the highest standards of patient safety.
Contact Operon Strategist today to learn more about how we can help your company navigate the regulatory landscape and bring innovative medical devices to market.
