Which statement about FDA approvals for medical devices is true?

Which statement about FDA approvals for medical devices is true?

• A. They require clinical proof of safety and effectiveness.
• B. They require no review of technical details.
• C. They are issued for devices regardless of predicate status.
• D. They require only regulatory paperwork, with no clinical data.

Answer: (A)

Premarket actions for medical devices are driven by evidence of safety and effectiveness for the intended use. For higher‑risk devices, this almost always means clinical data from trials to show that benefits outweigh risks. Even for devices cleared by substantial equivalence to a predicate, the FDA requires evidence that the device is as safe and effective as the predicate, which comes from data rather than just paperwork. So, the statement that FDA approvals for medical devices require clinical proof of safety and effectiveness is the best choice. The other options miss important parts of the process: the FDA does review technical details, predicate status influences the clearance path but doesn’t make it irrelevant, and approvals aren’t granted on regulatory paperwork alone without supporting data.

Premarket actions for medical devices are driven by evidence of safety and effectiveness for the intended use. For higher‑risk devices, this almost always means clinical data from trials to show that benefits outweigh risks. Even for devices cleared by substantial equivalence to a predicate, the FDA requires evidence that the device is as safe and effective as the predicate, which comes from data rather than just paperwork. So, the statement that FDA approvals for medical devices require clinical proof of safety and effectiveness is the best choice. The other options miss important parts of the process: the FDA does review technical details, predicate status influences the clearance path but doesn’t make it irrelevant, and approvals aren’t granted on regulatory paperwork alone without supporting data.