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Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485

 
• By Shawn M. Schmitt

Melissa Torres, a US FDA official who is one of many working on the agency’s revision of the Quality System Regulation, offered a few nuggets of news about the process on 8 June. Among them: device makers will have “a few years” to comply with the new QSR; the Quality System Inspection Technique (QSIT) will change; investigators and device center staff will undergo training; and more.

QSR-ISO_193503416

Medtech manufacturers will be given “a few years” to comply with the US Food and Drug Administration’s retooled Quality System Regulation, which is in the process of being harmonized with international quality systems standard ISO 13485:2016.

So says Melissa Torres, associate director for international affairs in the FDA's Center for Devices and Radiological Health (CDRH), who has been involved in the QSR revision process since 2018.

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