Medtech Insight

FDA’s Draft QMSR: 3 Experts Read More Stakeholder Comments So You Don’t Have To

Part Two Of Two

01 Jun 2022

• By Shawn M. Schmitt

The second of two parts: Industry experts Vincent Cafiso, Kim Trautman and Dennis Gucciardo spoke with Medtech Insight about noteworthy comments on the US FDA’s proposed Quality Management System Regulation.

A stakeholder. — Stakeholders had their say on the FDA's proposed quality systems rule • Source: Shutterstock

As of 1 June the US Food and Drug Administration has released online 69 stakeholder comments on its draft Quality Management System Regulation. When finalized, the QMSR will replace the agency’s aging Quality System Regulation (QSR).

The QMSR is a result of the FDA’s years-long initiative to harmonize the QSR with international quality systems standard ISO...