Medical devices are broadly defined as any instruments, medicines, medical products, or medical services which are specifically recommended, available for use, and used for application by a human being. The United States federal government approves a wide range of medical devices, including insulin pumps, glucose meters, blood pressure monitors, and surgical catheters. Each of these devices is intended to improve the quality of life and reduce the risk of disease in one’s daily life. These devices also provide safety and increased functionality, making them essential medical equipment.
The Food and Drug Administration (FDA) regulates the manufacturing of medical devices. It inspects drugs, biological agents, and devices for potential hazards in food for human and animal consumption. Medical Device Manufacturers must register with the FDA to manufacture drugs and biological agents for medical purposes. They also need to submit detailed information on the manufacturing methods for all their medical devices to the FDA.
The FDA regulates not only the manufacture of medical devices but their distribution. It has been found to be responsible for the regulation of electromagnetic radiation-emitting products such as mobile phones, global-positioning systems, television sets, personal digital assistants, and laptops. It has been responsible for the monitoring of the effectiveness of hearing aids, blood pressure monitors, and pacemakers. The Mobile Medical Application Activity and Marketing Monitoring Guidelines released by the FDA provide guidelines for the voluntary industry certification of medical applications.
For both manufacturers and distributors of radiation-emitting products, to maintain a CSA regulated status, they need to submit to the FDA yearly. To maintain this status, medical devices need to comply with all the CSA regulations, notifications, listing requirements, listing exclusions, and labeling. Manufacturers must notify the FDA about any product that is modified, produces a new form, or results in an altered physical form. This allows the FDA to monitor compliance and prevent the possibility of the non-compliance with the CSA regulations.
Manufacturers of medical devices based on cooperation with other manufacturers have a legal obligation to make available clinical data and technical reports that comply with the CSA. They have an obligation to ensure that clinical information from clinical trials are made available to regulatory control organizations. They have to inform the FDA about safety, quality, manufacturing process, quality control methods, post marketing activity, medical device recall information, and any other relevant information. All these information are required to be submitted to the FDA on an annual basis. Manufacturers are not required to provide a clinical study citation at this time. However, if they do, they are required to provide supporting citations and clinical study reports.
According to the FDA, all devices must be capable of fulfilling the intended purposes. This means that a device that helps to increase patient comfort should have appropriate levels of comfort, and a device that assists in preventing unnecessary movement should have minimal interference with patients’ ability to perform their daily activities. Thus, it is necessary for manufacturers to conduct studies to determine the safety and efficacy of medical devices based on their intended purposes.
The FDA defines the term “good clinical practice” as having reasonable evidence that the use of the device provides the expected benefit to the patient for whom it is intended. For instance, a device that helps to prevent the occurrence of sleep apnea is considered “good clinical practice” if it prevents the sleep apnea from occurring. However, if the device also increases patient comfort and reduces stress, it would be considered “good clinical practice” to conduct studies that indicate its effectiveness in reducing sleep apnea or improving the patient’s quality of sleep.
Manufacturers must also demonstrate to the FDA that their intended action cannot be prevented by a generic or competing device that has the same function. For example, if a generic cardiac monitor was designed to prevent interruptions in coronary flow, the generic device might not be able to prevent cardiac arrest. Thus, even though the generic device can prevent interruptions in coronary flow, it could prevent the cardiac arrest from occurring.