In this week’s roundup: Looking for upclassifications in six important device categories in Australia; MCIT repeal will lead to stakeholder meetings and potential congressional action; Cures 2.0, real world evidence, and decentralized trials; Califf nomination; FDA COVID-19 diagnostic updates; China targets next-gen sequencing standards, digital therapeutics, and more.
What we’re watching for:
Australia reclassifications. New rules underlying risk classifications for multiple device categories are set to kick in on November 25 in Australia. In general, the changes will result in higher risk classes for six targeted device categories:
- Devices composed of substances introduced to the body through an orifice or applied to the skin
- Active implantable devices
- Active devices for therapy with a diagnostics function
- Spinal implants
- Devices that administer medicines or biologicals by inhalation
- Devices used in direct contact with the heart, central circulatory or central nervous systems.