The Safe Medical Devices Act of 1990 and its subsequent Medical Devices Amendments of 1992 give authority to the Food and Drug Administration (FDA) to regulate and enforce the manufacturing, distribution, and reporting of faulty medical devices and products. Therefore, manufacturers, importers, distributors, and user facilities are all required to report to the FDA when adverse events occur in relation to these products and devices. Many people throughout the U.S. rely on effective medical products and devices every day, where problems and malfunctions can result if life-threatening situations. Without such regulations and reporting, the correction of these problems may either be slow or non-existent, and the trust of the health care system in general will be depleted greatly. People need to trust their medical products so that they have faith in obtaining the necessary products for their lives, while at the same time they are aware of the dangers that some products may inadvertently give, like radiation-emissions. Following are a couple more reasons why you need a safe and secure medical device and product supply network.
? The FDA requires manufacturing companies to report a product related death, injury, or malfunction within 30 days of the accident. Also, if the event or accident produces a need for remedial action in order to prevent harming public health, then a report must be filed within 5 days. Businesses and other companies may sometimes be reluctant to report these malfunctions quickly or their reports may get lost within bad ethics or slow management, and therefore it is assuring to the public that in the case of malfunctioning products or devices, the FDA will be able to efficiently identify and correct the problem. Also, manufacturers have to recertify annually and produce baseline reports about their products, while user facilities need semi-annual reports to help the FDA regulate how the manufacturers are complying with requested corrections and regulations.
? Foreign manufacturers must also have U.S. representatives to submit reports to the FDA and conduct or obtain information about investigations. This allows individuals to have much more available options for products and devices while allowing foreign manufacturers to reach markets in the nation; however, the FDA also needs to regulate the effectiveness of foreign products in order to ensure the U.S. individuals are always receiving the best care possible.
While putting a lot of trust in the cooperation of manufactures and distributors, the FDA also uses many innovative techniques to ensure the safety of the medical product supply chain. Some of these techniques include things like field exams and open access to information. These techniques combined with the regulations set upon manufacturers increases the FDA?s ability to reduce harm and achieve greater safety standards throughout the U.S. health care system.
Individuals need to know that the medical products and devices that they rely on for good health are working properly and effectively, and in order to maintain such a standard the FDA has implemented many regulations and policies that force manufacturers to report problems and correct problems immediately. The FDA seeks to help you, the consumer, by overseeing and ensuring the safety and security of the medicinal supply chain, responding to problems and adverse events effectively and efficiency, target areas of greater risk, and improve safety through better risk communication.
To learn more, visit our website about FDA Reporting for Safer Medical Products today and bookmark it to share with others!
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