The recent AAMI/FDA neXus medical device standards conference held in Washington DC shed light on the FDA’s future guidance on machine learning-enabled medical devices. Jessica Paulsen, the associate director for digital health at the FDA, discussed Predetermined Change Control Plans (PCCPs) during the event.
The PCCPs, jointly developed by the FDA, Health Canada, and the U.K.’s regulatory agency, aim to ensure the ongoing safety and effectiveness of AI/ML-enabled medical devices. These plans outline planned modifications, protocols for implementation and control, and impact assessments.
While initially focused on AI/ML products, the FDA has the authority to expand the use of PCCPs under the Food and Drug Omnibus Reform Act of 2022. Paulsen emphasized the specificity of PCCPs to individual devices, not entire device classes.
The conference attendees engaged in discussions around interpreting the guiding principles behind PCCPs. RAPS reported on Paulsen’s insights, indicating a potential need for further FDA guidance on the matter.
The industry eagerly anticipates additional clarity from the FDA on PCCPs for Machine Learning-Enabled Medical Devices, shaping the future landscape of regulatory standards in this space.
Frequently Asked Questions (FAQs) Related to the Above News
What are Predetermined Change Control Plans (PCCPs)?
Predetermined Change Control Plans (PCCPs) are plans developed by the FDA, Health Canada, and the U.K.'s regulatory agency to ensure the ongoing safety and effectiveness of AI/ML-enabled medical devices. They outline planned modifications, protocols for implementation and control, and impact assessments.
What devices are PCCPs initially focused on?
PCCPs are initially focused on AI/ML products, but the FDA has the authority to expand their use under the Food and Drug Omnibus Reform Act of 2022.
Are PCCPs applicable to entire device classes?
No, PCCPs are specific to individual devices and not entire device classes.
What discussions took place at the AAMI/FDA conference regarding PCCPs?
Conference attendees engaged in discussions around interpreting the guiding principles behind PCCPs, with a focus on the need for further FDA guidance on the matter.
What is the industry's expectation regarding future FDA guidance on PCCPs?
The industry eagerly anticipates additional clarity from the FDA on PCCPs for Machine Learning-Enabled Medical Devices, which will shape the future landscape of regulatory standards in this space.
Please note that the FAQs provided on this page are based on the news article published. While we strive to provide accurate and up-to-date information, it is always recommended to consult relevant authorities or professionals before making any decisions or taking action based on the FAQs or the news article.
