IVDs used in FMT screening exempt from Class 4 IVD requirement

AusBiotech welcomes the Therapeutic Goods Administration (TGA) decision to exempt laboratories’ requirement to register Class 4 in-house IVDs on the Australian Register of Therapeutic Goods (ARTG) for stool donor screening test kits.

Laboratories using Class 4 in-house IVDs to detect the presence of transmissible agents in samples to assess suitability for faecal microbiota transplants (FMT) no longer need to register on the ARTG, following public consultation.

The TGA notes that “The exemption is intended to allow laboratories time to work with the TGA to establish processes that allow adequate data to be generated which supports their performance as Class 4 in-house IVDs. This data will contribute to the clinical evidence needed to address some of the residual risks associated with detection of specific organisms in the stool samples of healthy donors, and their relevance to potential transmission.”

As the voice of industry, AusBiotech’s submission to the TGA’s draft Guidance for Class 4 in-house IVDs for screening Faecal Microbiota Transplant (FMT) donors outlined the need for the Class 4 IVD exemption for stool donor screening test kits be a permanent exemption, and shared the industry’s desire to work with the TGA to support and foster this emerging industry with a fit-for-purpose framework to screen FMT donors, given the small sample size, data validation and resourcing (cost, capacity and time) barriers being faced

Under the TGA’s IVD Framework, an IVD is intended to detect the presence of, or exposure to, transmissible agents in blood, stool or other samples in order to assess suitability for FMT transplant is regulated as a Class 4 IVD (or Class 4 in-house IVD).

For the majority of blood tests being proposed for FMT donors, there are already Class 4 IVDs included in the ARTG that are intended for screening, however there are currently no Class 4 IVDs in the ARTG that are approved for testing of stool specimens for the purpose of screening donors for the manufacture of FMT products.

The amendments also provide for a requirement for these laboratories to notify the TGA so that the regulator is aware of the tests being used for donor screening purposes. The TGA will monitor and review this exemption to determine if it is still needed in the future.

The TGA notes that guidance will soon be published by the TGA Medical Devices Authorisation Branch to assist laboratories in meeting the new IVD regulatory amendments. These will outline the TGA’s expectations around the technical considerations for these tests, in line with the conformity assessment procedures and National Pathology Accreditation Advisory Council (NPAAC) requirements.

Australia broke new ground as the first country globally to provide regulatory approval for faecal transplants when it approved an FMT therapy in late 2022. The introduction of faecal transplants has provided a new and welcome approach to treating difficult bacterial infections, with the number of approved therapies steadily growing globally.

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