While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for changes in many other areas, according to a US Food and Drug Administration (FDA) official.
Speaking at the AAMI/FDA neXus medical device standards conference hosted by the Association for the Advancement of Medical Instrumentation (AAMI) on 21 February, Jessica Paulsen, associate director for digital health at the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH), added that the agency and industry are still learning how to apply the recently authorized regulatory tool.
While PCCPs were initially considered for products with artificial intelligence/machine learning (AI/ML) capabilities, Congress gave FDA much broader authority to use them under the Food and Drug Omnibus Reform Act of 2022 (FDORA). According to the statute, any medical device on the market may use a PCCP to make changes without requiring a new premarket submission. Paulsen said that FDA is still figuring out the limits of their authority and they plan on issuing final and draft guidances this year to help clarify what those limits are…
