SOCRA 18th Annual Device Research & Regulatory Conference
Talk
Demystification of In Vitro Diagnostic Clinical Studies
Fri, Apr 25, 2025 · 2:10–3:10 PM PDT Hyatt Regency Newport Beach
About this session
The presentation will cover several key aspects pertinent to IVD clinical trials, including the regulatory requirements outlined in section 812.2(c). It will also delve into important considerations for study design, the Institutional Review Board (IRB) requirements for reviewing non-significant risk devices, the protocols for informed consent and the use of leftover samples, and the procedures for submitting data to the FDA.
Speaker
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Sr. Clinical Program Manager · Hologic, Inc.
Speaker