Final answer:
Verification and documentation are critical for devices classified by the FDA, distinguishing between FDA-cleared and FDA-approved devices. Strict medical regulations by the FDA ensure safety but can also delay drug availability, making companies who must test drugs for years the losers in the system. The FDA's CDRH approves medical devices and ensures the safety of a wide range of products, from simple to complex technologies.
Step-by-step explanation:
Verification and documentation must be thorough and compliant for any device classified by the U.S. Food and Drug Administration (FDA) that is used in a field of practice. The FDA classifies medical devices and regulates their safety and efficacy. For instance, "FDA-cleared" devices are those that are proven to be substantially equivalent to predicate devices, while "FDA-approved" devices are new or substantially different and must demonstrate safety and efficacy.
This distinction is crucial for ensuring that medical protocols for cleaning or sterilizing equipment, as developed by government agencies or organizations like the AOAC, are adhered to by end-users such as hospitals and healthcare staff. When it comes to drugs, the FDA's Center for Drug Evaluation and Research applies different standards for new drugs, generic drugs, and over-the-counter drugs, with new drugs undergoing a rigorous New Drug Application (NDA) process to be approved as "safe and effective when used as directed."
Nonetheless, strict medical regulations may lead to losers in the system; often these are companies that bear the high costs and delays associated with long-term drug testing before market entry, hence potentially stalling the availability of life-saving drugs. The FDA's Center for Devices and Radiological Health (CDRH) plays a significant role in approving medical devices and ensures the safety performance of devices that emit electromagnetic radiation.
This oversight includes a vast range of products from daily use items like toothbrushes to complex technologies such as implantable brain pacemakers. Determining liability in the case of breaches in protocol or defective equipment involves assessing whether health-care providers or manufacturers have adhered to or provided flawed procedures and equipment, while also considering the government's responsibility in ensuring fail-safe use and maintenance of medical equipment and protocols.