Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.
Steve Silverman is a former compliance director for the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). He’s now head of The Silverman Group, a consultancy for industry.
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
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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.
