Question

There are three levels of FDA approval for medical devices, with Level 1 being advanced technological products such as pacemakers to Level 3 including devices such as bandagesA. TrueB. False

Answer 1

The answer is FALSE.

3 Levels of FDA's are:

• Class 1 - these are devices that contains low risk to the user or patient. Examples: bandages, bedpans, stethoscopes.
• Class 2 - devices that has moderate risk to the user such as wheelchairs.
• Class 3 - devices that implements and support life forms. These can be either inside (implanted) or not. Examples of this are: pacemakers and implants.