SOCRA CCRP Practice Exam

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What FDA regulations define in-vitro diagnostics?

21 CFR 809.10(b)
21 CFR 810
21 CFR 809.3(a)
21 CFR 50.1

The correct answer is: 21 CFR 809.3(a)

These options all refer to different parts of Title 21 of the Code of Federal Regulations (CFR), which outlines regulations for food and drugs. Option C, 21 CFR 809.3(a), specifically pertains to in-vitro diagnostics. Option A, 21 CFR 809.10(b), applies specifically to high complexity testing and would not cover all types of in-vitro diagnostic tests. Option B, 21 CFR 810, applies to certain medical devices, but not necessarily in-vitro diagnostics. Option D, 21 CFR 50.1, deals with informed consent for human subjects in clinical trials and does not pertain to the regulations for in-vitro diagnostics. Therefore, option C is the most accurate and relevant answer in regards to FDA regulations for in-vitro diagnostics.