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

More from Regulation

More from Policy & Regulation