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FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices

 
• By Brian Bossetta

The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.

FDA Pen and Pad
• Source: Shutterstock

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or packaging, new raw device materials, or certain software updates, the Food and Drug Administration says in a draft guidance document issued 21 August.

PCCPs allow manufacturers to obtain prior FDA blessing on changes they expect to make after the device comes to market, thus eliminating the need for additional marketing submissions for modifications...

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