In House IVDs for TGA notification

on Thu, 06/15/2017 - 06:38

Pathology laboratories in Australia are required to notify the TGA of IVD tests including in-house IVDs by July 2017. An ACS polocy document was prepared and published on this website to provide assistance with this process. This forum is provided to further discussion on this topic.

Neil McNamara's picture

The ACS policy document on in-house IVDs was prepared to assist with questions received in recent months as the TGA July deadline for notification approached. The ACS guidleine work group members assisted in preparation of the current document. TGA and RCPA representatives added comment. The document is a guide only, not binding. The NPAAC reference IVD document is the key article to be read in the first place. It is well written and gives quite clear instructions. The ACS document is meant only to assist flow cytometry laboratories with this notification process, as the majority of flow tests are in-house.

This document will be reviewed over the next year as more information is received from TGA as to how laboratories have flow completed this process. More open discussion will take place with ACS members and associates as further consensu is achieved in regards test nomenclature, classification and any other matters arising eg test validation.

A point of discussion was uniform test nomenclature. An inital list of common test names was suggested, with decisions made considering commonality, accuracy and consistency of terms. Excellent responces were made to produce what is hoped answers the original qustions risen. ACS members will be invited for further comment in coming months, with postings on this forum.

If you wish to make comment, register and comment on this forum or email clinicalguidelines@cytometry.org.au.

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