FDA seeks feedback on predetermined change control plans
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
Dive Brief:
The Food and Drug Administration has released draft guidance on medical device predetermined change control plans (PCCPs), which describe the changes companies can make to their devices without filing a new 510(k) or premarket approval supplement.
Pre-specifying changes could streamline the process of updating devices. The FDA first outlined how a PCCP might work in the context of medical devices that use artificial intelligence or machine learning, but it has also considered the framework for in-vitro diagnostics.
The draft, which the FDA published Thursday, covers the information about a PCCP that companies should include in their marketing submissions. The FDA is accepting feedback until Nov. 20.
Dive Insight:
The FDA introduced the term PCCP in 2019 in a proposed regulatory framework for updating software as a medical device based on artificial intelligence or machine learning. The administration has continued to use the term in ...
