AusBiotech is calling for feedback on newly drafted TGA guidance on the requirements for Class 4 in-house IVDs used for screening Faecal Microbiota Transplant (FMT) donors, and on the proposal to cease the current exemption for these IVDs that are used for FMT donor screening from inclusion in the ARTG from 1 July 2025.
While there are several Class 4 IVDs already included in the ARTG for the majority of FMT donor screening tests that are intended to detect specific blood-borne diseases, there are currently none that are approved for testing stool specimens for screening donors for the manufacture of FMT products.
An extension was granted to temporarily exempt these devices to allow legal supply and create time for providers to generate sufficient data to support the performance of these devices, however, generating sufficient data in such small sample sizes has proven challenging, and removing the exemption will increase the time and financial burdens significantly. AusBiotech is concerned that this will impact the emerging industry without increasing the existing quality and safety requirements and seeks commensurate regulatory measures.
The purpose of the guidance is to assist testing laboratories to understand the requirements around the regulatory and technical considerations for these tests, so to demonstrate compliance with the relevant essential principles and the conformity assessment procedures.
AusBiotech is developing a response to the draft guidance through its Regulatory Affairs Advisory Group
