In Vitro Diagnostics: Preparing for an FDA Inspection Under QMSR
IVD inspection preparation should use the current QMSR framework and the requirements that apply to the product, manufacturing activities, labeling,…
Category
Category: IVD & Diagnostics
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IVD Reagent Lot Traceability: From Kit Label to Production History
IVD labeling requirements include a lot or control number traceable to production history. A readiness review should test the connection…
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RUO IVD Products: Why the Label Alone Does Not Set Intended Use
A research-use-only statement must be consistent with the manufacturer’s intended use. FDA’s RUO/IUO guidance looks beyond the presence of a…
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IVD QMSR Inspections: Are Internal Audit and Management Review Records Accessible?
FDA’s QMSR FAQs state that management review, quality audit, and supplier audit reports are inspectable. The former Part 820.180(c) exceptions…
