FDA New Draft Guidance to expand the use of Pre-determined Change control Plans (PCCPs) from just AI/ML to now all medical devices
By Elle Winn, Mittal Consulting On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices. Predetermined change control plans (PCCPs) are FDA-authorized plans to implement changes to a medical device at a later point that are included in and approved in a marketing submission to the […]