The nurse discusses the use of a newly marketed orthopedic device to a client. Which of the following is an accurate statement regarding the safety of the device?

Question

a. The FDA ensures basic standards prior to allowing any drug or new product to be marketed.
b. The device is safe to use because a number of clients have used it.
c. The manufacturing company is responsible for ensuring the safety of a device before distributing it to the public.
d. The Drug Enforcement Administration handles all the safety requirements of new products.

Answer 1

a. The FDA ensures basic standards prior to allowing any drug or new product to be marketed.
FEEDBACK
a. The FDA ensures basic standards prior to allowing any drug or new product to be marketed. The FDA can recommend withdrawal of an existing product or medication if it is deemed that the product's or drug's benefit no longer outweighs its risk.
b. All medications and new products are scrutinized going through many studies and trials prior to marketing. The DEA handles the safety needs associated with controlled substances. .
c. Pharmaceutical companies do have safety guidelines; however, the ultimate decision of a product's safety rests with the FDA.
d. The FDA can recommend withdrawal of an existing product or medication if it is deemed that the product's or drug's benefit no longer outweighs its risk.