Medical Device Classification & Recalls

Question 0

Class II Device

Answer 0

Potential risk great enough to warrant a high level of regulation. Most types of sterilization equipment, biological and chemical indicators. They are subject to performance standards, post market surveillance studies and guidelines on labeling.

Question 1

Class I Device

Answer 1

Low risk devices like hand held instrumentation and ultra sonic cleaners. They are required to be registered, have medical reporting, quality system regulations and labeling.

Question 2

Class III Device

Answer 2

The most strictly regulated. Heart valves, pacemakers and other life-sustaining devices. Has to have pre-market approval from the FDA to demonstrate safety and effectiveness.

Question 3

Class I Recall

Answer 3

High risk. This product has a chance to cause serious health problems or death.

Question 4

Class II Recall

Answer 4

Less serious risk. The product might cause temporary or reversible health problems or a remote chance that the device will cause serious health problems.

Question 5

Class III Recall

Answer 5

No risk. There is little chance that using the product will cause health problems.