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

Question

Dean Burgess

Computers & Technology

1 April, 18:15

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

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Terry Quinn · 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.