Health Canada is seeking stakeholder feedback on a revised plan to help manufacturers classify in vitro diagnostic devices based on risks.
The draft guidance document — which will replace a version released in 1998 — is intended to clarify how to apply the rules set out in the Medical Devices Regulations for IVDDs. The guidance was revised to provide greater clarity and updated examples, according to Health Canada.
The draft guidance spells out the rules and provides explanations and examples for several types of IVDDs, including those used for donor screening, patient management purposes and immunological typing, as well as those that determine disease status or immune status.
Included in the document is a flow diagram to help manufacturers apply the rules to determine in what class an IVDD belongs.
The revision follows Health Canada’s release of guidance on the risk-based classification system for non-in vitro diagnostic devices last June, as well as guidance on supporting evidence for new and amended license applications for Class 3 and 4 devices not including IVDDs from July 2012.