FDA updates 19-year-old replacement reagent policy for IVDs

Regulatory NewsRegulatory News
| 18 August 2022 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Tuesday finalized its guidance explaining its policies for replacement reagents and instrument families for in vitro diagnostics (IVDs), replacing an earlier policy issued in 2003.
The guidance outlines FDA’s policy to allow IVD makers to avoid having to submit new 510(k)s for certain changes to their tests and supersedes the 2003 version. FDA issued a draft version of the guidance for comment in 2017. (RELATED: New draft guidance looks to update FDA's replacement reagent policy for IVDs, Regulatory Focus 22 December 2017)
“Specifically, it addresses a manufacturer's application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument that was previously cleared, or that is a member of an instrument family from which another member has been previously cleared,” FDA explains.
Among the revisions made from the draft version, FDA said it will now allow, “in certain limited situations,” point-of-care IVDs to be within scope of the guidance, rather than being “expressly identified as outside the scope.”
FDA also added flowcharts, updated some of the examples provided, and a provided additional clarification of terminology within the 24-page guidance.
“FDA believes this guidance is important for public health as FDA continues to promote more timely availability of a wider array of clinical laboratory tests for patient benefit,” the agency writes, noting that the new guidance “incorporates concepts and recommendations” from its 510(k) change guidance and its 510(k) substantial equivalence guidances.
The guidance itself applies specifically to IVD test systems that are regulated by the Center for Devices and Radiological Health and that consist of “a cleared assay that is run on an automated laboratory instrument specified by the assay manufacturer.”
FDA notes that the guidance does not apply to modifications other than application of a cleared assay to an additional instrument, Class III devices, devices indicated for use in support of blood banking practices, devices indicated for prescription of over-the-counter home use or Clinical Laboratory Improvement Amendments (CLIA)-waived tests.
FDA, Federal Register notice


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