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FDA Draft Guidance Clarifies Policy on Replacement Reagents and Instruments

NEW YORK (360Dx) – The US Food and Drug Administration today released a draft guidance intended to update and provide clarity for its staff and for manufacturers of in vitro diagnostic devices about its replacement reagent and instrument family policy.

Among other advice, the draft guidance includes recommendations and information regarding CLIA categorization when the manufacturer determines that a 510(k) is not needed. The FDA noted in its draft document that it is providing additional clarity to help itself and manufacturers better apply the concepts in its 2003 guidance, and "to ensure that its full benefits are realized."

The agency's 2003 guidance described a mechanism for manufacturers applying an assay 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. That mechanism also applies to an assay that was previously cleared for use with a specified instrument based on performance characteristics.

The FDA said that the draft guidance pertains to IVD test systems regulated by the agency's Center for Devices and Radiological Health comprising an assay subject to FDA clearance that is run on an automated lab instrument specified by an assay manufacturer. It specifically "addresses a manufacturer's application of a previously cleared assay to an additional instrument that was previously cleared or that is a member of an instrument family for which another member has been cleared," according to the FDA document.

The draft guidance also applies to a large range of marketed Class I "reserved" or Class II 510(k) IVD test systems intended for use in moderate- or high-complexity CLIA-regulated labs, the FDA added. Most automated clinical instruments by themselves are Class I devices that are exempted from 510(k) regulations, it said, but reagent/instrument systems are considered "combination devices" and require FDA clearance if "there are claims regarding a reagent in the system that meets the definition for a Class I "reserved" or Class II device."

The draft guidance is open for public comment for 90 days.

The FDA also released two draft guidances on Friday outlining the regulatory requirements for molecularly guided personalized treatments and investigational in vitro diagnostics that identify those molecular changes in patients in clinical trials.