Australia’s Plan to Exempt Some Device Software Draws Support

A proposal by Australia’s Therapeutic Goods Administration to exempt from regulation certain classes of device software that present a lower risk to safety drew broad support in written comments to the agency.

Sydney-based Cochlear said that it supported excluding clinical decision support software from the medical device framework in Australia and said it may also be appropriate to exempt all medical device software that is purchased directly by patients for their own individual use.

Roche Diagnostics said it applauds the agency’s plan for “qualification of software products in order to support a risk-based, fit-for-purpose regulatory paradigm for software,” adding that the approach is consistent with what has been taken by the EU, Canada and the U.S.