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

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, and the agency soon after added the QSR redo...

Device-makers use ISO 13485 to ensure quality systems compliance with regulators in a variety of countries, including Canada, Japan, Australia and the 28 member states of the European Union.

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