Arista AH is FDA classified as which class for surgical indication?

• A. Class 3.
• B. Class 2.
• C. Class 1.
• D. Class 4.

Answer: (A)

Understanding how the FDA classifies medical devices helps explain why this hemostatic agent is placed in the highest risk category. Devices are grouped into Class I (low risk), Class II (moderate risk with special controls), and Class III (high risk, often requiring premarket approval) based on potential harm if they fail and how invasive their use is. Arista AH is a topical hemostatic agent used during surgery and remains in contact with tissue. Because it operates in a critical area where failure or adverse reactions could seriously impact outcomes, the FDA treats it as a higher-risk device that requires evidence of safety and effectiveness through a premarket approval process. That pathway corresponds to Class III. Lower classes would not fit its risk profile, and there is no separate Class IV in FDA device classification.