Changing Your Device Manufacturing Site Location? Read This US FDA Proposal
This article was originally published in SRA
The US Food and Drug Administration has issued a draft guidance to address submission and inspection requirements when a company moves where its device manufacturing activities take place, either within a single facility or to a completely new location, or to a contract manufacturer1. It's the latest effort by the FDA to clarify what has historically been a nebulous area for manufacturers: what steps to take when making a modification to an approved device.