Compliance Corner: 4 Things You Should Do Now To Prep For FDA’s New QMSR Reg

Sure, medical device makers will have a full year – or perhaps more if industry has its way – to comply with the US Food and Drug Administration’s proposed Quality Management System Regulation (QMSR) once it’s finalized. But there are steps manufacturers can take now to prep for the forthcoming rule, an attorney says.

The FDA released its draft QMSR rule last month. When finalized, it will replace the agency’s Quality System Regulation, which has been the bedrock rule for making safe and effective devices in the US since the mid-1990s. The QMSR is a result of the FDA’s years-long work harmonizing the QSR with international quality systems standard ISO 13485:2016