Sponsors may want to use predetermined change control plans (PCCPs) to describe planned modifications to medical devices, such as changes to sterilization or packaging, new raw device materials, or certain software updates, the Food and Drug Administration says in a draft guidance document issued 21 August.
FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices
The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.
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