Which agency is responsible for categorizing new test methodologies?

• A. CAP
• B. CMS
• C. FDA
• D. CDC

Answer: (C)

Regulatory oversight of diagnostic tests is handled by the agency that classifies and regulates medical devices used for patient testing. The FDA is the agency responsible for in vitro diagnostic devices, including new test methodologies; they determine how a test is categorized and the regulatory pathway (such as premarket clearance or approval) needed before the method can be marketed, ensuring safety and effectiveness. Other organizations have important roles in labs—CAP focuses on accreditation and quality standards, CMS handles reimbursement and CLIA compliance, and CDC provides public health guidance—but they do not categorize new test methods. That categorization and oversight come from the FDA.