Final answer:
Companies must follow strict procedures regulated by the FDA when manufacturing drugs and medical devices to ensure safety and efficacy. The CDER and CDRH are the specific branches responsible for drug and device regulations. These include premarket approval, postmarket surveillance, and risk management plans for drugs and devices.
Step-by-step explanation:
When manufacturing drugs and medical devices, companies must adhere to standardized procedures set forth by regulatory agencies such as the Food and Drug Administration (FDA). For instance, the Center for Drug Evaluation and Research sets distinct requirements for new drugs, generic drugs, and over-the-counter drugs.
A rigorous approval process, including the New Drug Application (NDA), is in place for new drugs to ensure they are safe and effective for use. The Center for Devices and Radiological Health (CDRH) oversees the premarket approval of medical devices, from toothbrushes to complex brain pacemakers. They also regulate the performance and safety of devices that emit electromagnetic radiation.
The FDA's regulations are also concerned with postmarket safety. For certain drugs and equipment, this includes mandatory Phase IV trials or risk management plans to monitor safety after they are released into the market.
Moreover, protocols for cleaning or sterilizing medical equipment are often established by the FDA and organizations like the AOAC. Medical device manufacturers adopt these protocols, and end-users such as hospitals must comply with them to avoid liability for harm caused by improperly cleaned equipment.
In the context of ensuring safety and efficacy, while many are protected by these regulations, some companies may suffer due to the extensive time and resources required to bring a new drug or device to market. This could potentially limit access to innovative treatments for patients. The FDA and manufacturers both play a role in ensuring the use and maintenance of medical equipment and protocols are without fail, to avoid liability and maintain public trust in medical systems.