Question

Biomedical FDA classification question...

Classify the following devices according to the FDA classifications: Write 1, 2, or 3 to show what Class the device is: Number Device: Band-Aid Scalpel Herpes Assay Coronary Stent Eye Glasses 4 6 Surgical Lamp 7 Electric Toothbrush Ultrasound Contrast Catheter Bone Densometer 10

Answer 1

Classify the following devices according to the FDA classifications: Write 1, 2, or 3 to show what Class the device is: Number Device: Band-Aid Scalpel Herpes Assay Coronary Stent Eve Glasses Surgical Lamp Electric Toothbrush Ultrasound Contrast Catheter Bone Densometer 2 3 4 2 2 2 10

The FDA classified medical devices in to three classes and they are Class I, Class II, and Class III. These classifications are based on the risk associated with the devices and for necessary control to assure the safety and efficacy of the medical device. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.