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The Food and Drug Administration has released draft guidance on medical device predetermined change control plans (PCCPs), which describe the changes companies can make to their devices without filing a new 510(k) or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 c...
