IVD Point of Care Tests Go Under the Spotlight

The Therapeutic Goods Administration (TGA) ACMD (Advisory Committee on Medical Devices) recently held a meeting to review the requirements for IVD Point of Care Tests (class 3 IVDs) when it comes to performance and testing.  The IVD regulation is reasonably new (having come into force in 2010) and new IVD manufacturers are still in the process of better understanding requirements.

The ACMD is a statutory advisory committee established by the Therapeutic Goods Regulations 1990. The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA’s regulatory decision making and other regulatory processes. The ACMD provides advice to the TGA on, amongst other things, matters relating to premarket conformity assessment and post market monitoring and contributes to the final decisions made on device applications.

During the meeting held in March 2013, the committee considered point of care tests broadly. Point of care testing is performed outside the laboratory environment, near to or at the side of the patient. The committee considered acceptable levels of sensitivity and specificity of these types of IVD medical devices.

The ACMD also discussed the changes to premarket assessment requirements for medical devices – as per KD&A’s news story, however no additional information has been given by the TGA regarding discussion outcomes.

The next meeting of the ACMD is scheduled for 28 June 2013.

KD&A can provide assistance with IVD applications to the TGA for all classifications of IVD. Contact us for a personalised quotation.