A complex medical device must be proven safe before the FDA will allow them to be sold in the US.
This statement is true.
What is FDA?
- The United States Food and drug administration.
- It protects the public health by confirming the drug, biological products, medical devices, etc.
FDA work on medical devices
- FDA requires a large amount of evidence that a device is working well–and safely–before allowing it onto the market.
- FDA classified medical devices regulatory in 3 risk categories.
- Class I devices are deemed low risk and are almost always exempt from scientific review.
- Class II devices are considered to pose a medium risk and could hurt patients if misused.
- Class III is reserved for the 10 percent of devices that pose the greatest risk. They’re typically used to support life and are often implanted, according to the FDA.
Thus, we can say that complex medical device must be proven safe before the FDA allow them to use because they can be harmful to human health.
You can learn more about FDA here:
https://brainly.com/question/1317177
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