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US FDA Updates Policy For Adding Cleared Assays To Additional Instruments

 
• By Elizabeth Orr

Under a draft guidance, IVD manufacturers wouldn’t need to submit a new 510(k) if they were clearing an assay for use with an instrument similar to those it was already cleared on.

A draft guidance from US FDA clarifies when manufacturers considering the use of in vitro assays on multiple instruments would need to submit a fresh 510(k).

The Dec. 18 draft, which FDA says 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,” will replace a 2003 guidance. It incorporates concepts from the agency's October guidance on 510(k) modifications

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