FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices

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or packaging, new raw device materials, or certain software updates, the Food and Drug Administration says in a draft guidance document issued 21 August.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 described in the plan. They were established under the Food and Drug Omnibus Reform Act of 2022, but the agency had previously detailed expectations around PCCP use only for devices using artificial intelligence or machine learning