We are seeking feedback on two new guidance documents developed as part of the proposed new risk-based application audit framework:
1. Draft Guidance - Selection criteria for non-mandatory application audits.
This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria.
2. Draft Guidance - Medical device application audits: Case management process.
This guidance document outlines the case management model that will be used throughout the life cycle of an application audit. It details the process, timeframes, and the role of the TGA case manager.
