FDA Classifications

Question 1

What does the U.S. Food and Drug Administration (FDA) do?

Answer 1

Ensures medical devices are safe and effective.

Regulates medical device manufacture, sterilants, disinfectants, packaging, sterilizers, biological indicators, and single-use devices.

Question 2

FDA Medica Device Classification

Answer 2

Class I: Low-risk devices (general controls)

-EX: hand-held surgical instruments, hospital beds, and ultrasonic cleaners.

Class II: Moderate-risk devices (performance standards & specific guidelines)

-EX: Most sterilization equipment, BIs, CIs, wraps, etc.

Class III: High-risk devices (requiring premarket approval)

-EX: Heart valves, pacemakers, and other life-sustaining devices.