Morgan Lewis partner Dennis Gucciardo gives a quick take on the US FDA’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation.
Dennis Gucciardo is a partner at the law firm Morgan Lewis.
This is his quick take on the US Food and Drug Administration’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation. The QMSR harmonizes the QSR with international quality systems standard ISO 13485:2016
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
