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In addition to drugs and devices, the FDA also has the authority to review medical and surgical procedures for their safety and effectiveness.

A. True
B. False

1 Answer

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Final answer:

The FDA does not review medical and surgical procedures for safety and effectiveness; its authority is over the regulation of products such as drugs and medical devices. The 'losers' from strict FDA regulations include patients waiting for access to new treatments still in the approval process.

Step-by-step explanation:

The statement that the FDA has the authority to review medical and surgical procedures for their safety and effectiveness is false. The FDA's jurisdiction primarily covers the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter drugs, vaccines, medical devices, and more. However, the FDA does not have the authority to review medical and surgical procedures. Health care providers and medical institutions typically govern the use of these procedures, often following guidelines established by medical societies and through peer-reviewed clinical studies.

Concerning the safety and efficacy of medical substances and devices, the FDA plays a critical role in regulating the medicines that pharmacies can sell. While the system in place protects the public from unsafe drugs, there are anonymous losers who may suffer due to stringent regulations. These losers are often patients who might need access to experimental treatments or drugs that are still undergoing the lengthy approval process, which can be delayed due to rigorous safety and efficacy testing.

Moreover, the FDA is integral in ensuring the security of the food supply and in the development of medical products to respond to health threats, thus advancing public health. Yet, it must balance this role with the need to promote access to new and potential treatments in a timely manner.

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