ANALYTE-SPECIFIC REAGENTS ARE APPROPRIATELY CLASS I 510(k)-EXEMPT, INDUSTRY MAINTAINS; LABORATORIES SHOULD BE SUBJECT TO STRICTER REGS -- HIMA
This article was originally published in The Gray Sheet
Executive Summary
FDA regulations on Class II and Class III analyte-specific reagents (ASRs) should make the laboratories using the products to develop in-house assays responsible for compliance, not ASR manufacturers, the Health Industry Manufacturers Association says in recent comments to the agency on its proposed policy to regulate ASRs. "HIMA recommends that in the limited instances where FDA determines that Class II or Class III regulation of in-house developed assays is necessary, the regulations should be applied to the laboratory performing the assay not the ASR supplier."
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