Biological safety evaluation has always been a thorny aspect of device development and regulatory review. For too long, the approach has been to spend up big on lots of laboratory testing and tick the boxes against the ISO 10993 guidance. However expectations are changing rapidly. The latest version of ISO 10993 is based firmly in a risk management framework, a further revision in the works cements this position – and regulators are following suit.
The US FDAs guidance now firmly recognises a risk management approach that’s as much about understanding materials formulations and chemistry as it is about animal testing. And perhaps most surprising of all, the China FDA is taking a much more enlightened approach – embracing risk management and literature based submissions.
Join Arthur Brandwood – Principal Consultant (and participant in ISO 10993 standards writing for over 20 years) to take a look at the evolving practices for regulatory review of biocompatibility.Download PPT Slides Contact Us