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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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Jan 5, 2021
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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
Computers and Technology
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Eishay
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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.
Raman Balyan
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Jan 11, 2021
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Raman Balyan
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