Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.

The much-maligned medical device tax was finally laid to rest Dec. 20, as President Donald Trump signed a spending bill that included a permanent repeal of the tax. The 2.3% excise tax on devices was brought into the statute via the Affordable Care Act (ACA), and its repeal brings much-needed breathing room to small device makers.

Seven years after an advisory hearing on the subject, the FDA has determined that cranial electrotherapy stimulation (CES) devices will be slotted as class III devices when used for depression. The decision comes despite a number of irregularities that took place at the February 2012 advisory hearing.