Listen to the podcast via the player below:
Device Week, 4 March 2022 – FDA Gets First Feedback On QMSR Draft Reg
In this episode of Device Week: A US FDA meeting on 2 March generated the first public comments the agency has heard on its proposed Quality Management System Regulation, including some industry concerns around when device makers would have to transition to the new QMSR, if finalized.
More from Regulation
More from Policy & Regulation
• By
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
• By
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
• By
The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.