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FDAnews Device Daily Bulletin

J&J, Medtronic Knock TGA’s Device Review Plan

June 22, 2017

Medtronic and Johnson & Johnson have criticized Australia’s Therapeutic Goods Administration for its proposed medical device review priority pathway.

In J&J’s remarks, it criticized the TGA proposal for what it perceived as allowing only for “front of queue” processing rather than accelerated assessment. The company also voiced concerns that the plan would exclude technologies without substantial clinical data available.

Medtronic offered a similar critique of the proposal’s expectation of  “clinical evidence,” which it suggested will restrict the pathway exclusively to devices that already have enough supporting data to comply with Australian guidance on clinical expectations. — Zack Budryk

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