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FDA Official: QSR/ISO 13485 Mash-Up On Track But Will 'Take Time'; CDRH's Shuren Open To 'Adopting More Standards'

 
• By Shawn M. Schmitt

The US FDA's plan to harmonize its Quality System Regulation with ISO 13485 is rolling along despite one FDA official's recent claim that only a "limited number of staff" are acquainted with the international quality systems standard. Meanwhile, CDRH Director Jeff Shuren says the medtech industry should "anticipate" that the agency will increasingly recognize more standards.

QSR-ISO_193503416

A plan by the US Food and Drug Administration to harmonize its Quality System Regulation with ISO 13485 is rolling along despite one FDA official's recent claim that only a "limited number of staff" are acquainted with the international standard.

In a blog post exactly one year ago, then-FDA Commissioner Scott Gottlieb announced that the two documents would be merged,...

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