ARTICLE SUMMARY:
In this week’s Pathways Picks: EU Reference Laboratory requirements for batch testing and performance verification of high-risk tests kick in October 1; FDA proposes to downclassify hepatitis B virus assays from PMA Class III to 510(k) Class II devices, and publishes draft guidance on chemical biocompatibility analysis and on its ASCA program; the UK opens up for applications to its AI Airlock pilot; Europe publishes a new health technology assessment guidance; and more.
Diagnostics Picks
EU launches Reference Labs, FDA downclassifies hep B tests:
Batch testing begins in the EU. Five Reference Laboratories (EURLs) designated under the IVD Regulation will start carrying out their regulatory responsibilities to perform batch testing and performance verification for select high -risk (Class D) diagnostics October 1. As of that date, notified bodies should start contacting the EURLs to make arrangements to perform batch testing of Class D tests that they’ve certified that fall within the clinical scope of the labs, according to an updated EU guidance published September 25. “It may not be possible to start the testing itself on this date,” the guidance states. “Testing should take place, on a case-by-case basis, as soon as all the arrangements such as proper installation and validation of any equipment are in place.” Notified bodies should also plan to reach out to EURLs to conduct performance verification on relevant Class D tests submitted to the bodies for review from October 1, the guidance explains. These requirements did not kick-in when the IVDR originally took effect in 2022 due to delays in recruiting and designating reference labs. The five designated labs can perform testing for diagnostics for detection or quantification of hepatitis and retrovirus infection, herpesvirus, d bacterial agents, or respiratory virus. They aren’t designated to address the other four IVDR-required clinical areas: arbovirus, hemorrhagic fever, parasites, and blood grouping.
510(k)s for hep B tests. Makers of various types of hepatitis B virus (HBV) assays will be able to launch new tests via the 510(k) rather than PMA process if FDA finalizes a proposal published this week. The September 24 proposed order, which follows a 2023 advisory panel recommendation, would downclassify qualitative HBV antigen assays, HBV antibody assays, and quantitative HBV nucleic acid-based assays from Class III to Class II devices. FDA says it has approved a total of 54 PMAs for these types of tests since 2000. The overall risk profile of the tests and available knowledge support the use of 510(k)s and other special controls as sufficient to provide a reasonable assurance of safety and effectiveness, FDA concludes. The agency has cited this downclassification as part of its broader effort to reclassify “most” IVDs to Class II.
