Medical Devices are products such as syringes, catheters, pacemakers, and other electronics fabricated for the therapeutic medical purposes. All Medical Devices produced and sold in the US must be regulatory compliant with the Food and Drug Administration (FDA). Failure to comply with the FDA can lead to severe consequences. If you were to ask me what the purpose of the FDA is in one sentence it would be: “The Purpose of the FDA is to protect the end user from harm”.
Regardless of your stance on regulation, whether we have too much or too little; there is one fact we can both agree upon: We want our medical devices to be quality products and thoroughly tested. No patient ever walked into the operating room and said: “Give me the crappiest Heart Lung Machine you got!”