ICE E6(R3) Clinical Quality Assurance Readiness Inspection Readiness Checklist for IVD & CDx Developers Overview

Clinical Performance Studies • 510(k) / De Novo / PMA / CDx PMA • US FDA & Global

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Who This Checklist Is For:

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This checklist is designed for IVD and companion diagnostic (CDx) developers who sponsor clinical performance studies in support of FDA regulatory submissions. It covers study design quality, GCP compliance, trial master file readiness, site and vendor oversight, and BIMO inspection preparedness - framed specifically for device and diagnostic study sponsors, not drug sponsors.

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Why BIMO matters for IVD/CDx companies:

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FDA's Bioresearch Monitoring (BIMO) program inspects the clinical studies that underpin IVD and CDx submissions - including 510(k), De Novo, PMA, and CDx PMA. Inspectors evaluate clinical sites, IRBs, and sponsor study management.

Deficiencies found at inspection can delay or derail a submission already under review. Readiness is not optional.​​

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Section 1 - Clinical Performance Study Design Quality

Section 2 - GCP Compliance & ICH E6(R3) Alignment

Section 3 - BIMO Inspection Readiness

Section 4 - Trial Master File (TMF) Integrity

Section 5 - Clinical Site Qualification & Oversight

Section 6 - Vendor, CRO & Laboratory Oversight

Section 7 - Statistical Analysis & Data Management

Section 8 - Submission Readiness & Post-Submission Preparedness

Section 9 -  Global & Ex-US Clinical Study Considerations