Australia’s Therapeutic Goods Administration (TGA) unveiled guidance Thursday explaining how a laboratory can meet in vitro
diagnostic (IVD) regulatory requirements.
The regulatory framework applies to IVDs manufactured and/or modified in-house, though those that are supplied outside of a laboratory or laboratory network, as well as those developed solely for research purposes, fall outside of the requirements’ scope, TGA clarified.
Australian laboratories’ transition period to comply with the IVD regulatory framework—set forth on 1 July 2010—ended on 30 June 2017.
Laboratories’ in-house IVDs, including screening tests, tests for disease susceptibility or predisposition and tests for disease monitoring, must be in compliance to be legally sold on the Australian market for testing on human samples to aid in clinical diagnosis or management.
Per the definition of 2002 regulations
, laboratory personnel can determine whether an IVD is considered in-house based on three situations—de novo
principles, scientific literature and the modifications that will cause a device to become in-house, following commercial release.
“The laboratory must document any changes made to a commercially supplied IVD, and be able to demonstrate that the changes have been appropriately validated to ensure that the assay performs safely and effectively,” TGA said.
Examples of modifications that create in-house IVDs are outlined in TGA’s new guidance. In addition to the clarifications on the in-house definition, the guidance specifies the definition of a laboratory network is limited to “a group of laboratory organisations that operate under a single quality management system (QMS).”
At a minimum, the QMS elements that networks should centrally manage include management reviews, internal quality audits, corrective and preventive actions, complaints and key element changes to the quality system documentation.
Information on how to comply with conformity assessment procedures for class 1-3 vs. class 4 in-house IVDs, such as obtaining National Association of Testing Authorities accreditation, and postmarket requirements are also provided. Additional exemption situations are detailed as well.
In addition to the TGA, other regulators have moved to provide policy clarifications on IVDs to spur innovation and support patient access.
In 2014, the US Food and Drug Administration (FDA) announced its decision to reverse course
on stance held for decades to regulate laboratory-developed tests similarly to IVDs. Also, FDA guidance on submissions to obtain the waivers needed to perform IVD tests of moderate to high complexity, individually or in conjunction with 510(k) clearances, were finalized
Further, the European Medicines Agency recently embarked on an overhaul of its IVD and medical device regulations. IVD manufacturers in the EU market are facing tight deadlines
to comply (though not as tight as device manufacturers) and many have yet
to implement the new regulations.
Regulatory requirements for in-house IVDs