Complex medical devices must be proven safe before the FDA will allow them to be sold in the US.
Answers
The FDA is an agency under the US Department of Health and Human Services. The FDA is responsible for the protection and promotion of public health through control as well as supervision of the food products, food safety, diet supplements, pharmaceutical drugs and vaccines, medical devices, bio pharmaceuticals, veterinary products etc.
The enactment of the Medical Device Amendments has made it compulsory that all new medical devices are required to be approved by the FDA or FDA clearance is needed before marketing to ensure the safety and effectiveness of the device.
The statement Complex medical devices must be proven safe before the FDA will allow them to be sold in the US" is absolutely True.
Drug and other complex medical devices are a part of the category of regulated products.
As a result of which these devices need to be tested by the Food and Drug Administration (FDA) before they can be sold in the US.