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International Briefs: Australia’s IVD Framework; NICE Supports Two Devices

Abbott weighs in on proposed amendments to Australia’s in vitro diagnostics regulatory framework. NICE gives thumbs-up to intubation and amniotic fluid leak detection devices.

Some 28 entities, including diagnostics makers Abbott Laboratories and Alere, submitted written comments on proposed amendments to Australia’s new regulatory framework for in vitro diagnostic devices. Posted online July 19 by Australia’s Therapeutic Goods Administration (TGA), the comments address amendments proposed by TGA on April 30, including proposals to give IVD manufacturers more time to comply with certain regulatory requirements; modify the conformity assessment procedure for class 4, high-risk laboratory-developed, or “in-house,” IVDs; introduce selective performance evaluation of class 4, high-risk IVDs submitted for design examination; and define genetic tests as medical devices.

The Australian agency said it will take all the comments into consideration as it prepares a regulation impact statement and moves toward full implementation of the country’s new IVD regulatory...

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