In terms of medical and pharmaceutical products, consumers need to know that their products are not only going to work effectively, but also not illicit any adverse side-effects that are unknown to the consumer. Therefore, since 1984 the Food and Drug Administration(FDA) has required firms to notify them when complaints of malfunctioning medical products and devices come in, in order that the FDA may make prompt responses and quick changes to the manufacturers of such products.
In addition to this requirement for all firms, in 1990 further legislation was passed that allowed the FDA to trace and monitor all products in postproduction. These measures were created in order for the public to receive support and assurance that the medical products and devices that they trust their lives upon are working properly and efficiently.
Listed below are a couple more things you need to know about the FDA?s regulations regarding safer medical products. Along with the Department of Health and Human Services (HHS), both these governmental organizations seek to oversee the production and manufacturing of health products and medical devices in the U.S. and assure consumers that the products that they receive are effective and safe.
? Firms, marketing organizations, and user facilities are required to report cases of death and serious injury in relation to the products and devices to both the FDA and the product manufacturer. However, in 1992 further legislation was passed that required that all companies who buy and sell medical products and devices are to make these reports in the case of adverse events, which include malfunctions and product disabilities. Standard reports and annual summaries are also required in order to keep manufactures and producers completely of their productions and the product that they release.
? In terms of new devices that are set to release on the market, manufacturers and distributors must prove that the new device is similar to devices already on the market in relation to efficiency; also manufacturers must prove that these new products are not only safe but also reliable. Pre-market reviews with the FDA and HHS are mandatory for all new products reaching the market.
? Devices that are required for review and are overseen by the FDA and HHS include everything from bandages, tongue depressors, surgical clamps, MRI and Cat scans, and even pacemakers. People need to know whether or not every type of medical device will work properly and not cause any adverse affects, and therefore there is very few devices with the medical field that are exempt from these regulations. Additionally, all medical devices are grouped into class ratings, Class I, Class II, and Class III, which designate the safety and potential danger of such devices. Class I products include the tongue depressors and even things like reading glasses, while Class III designates pacemakers, heart valves, and other high risk medical devices. Malfunction of Class III, and even some Class II items, may result in the death of the person using the device.
Medical devices are a very important part of people?s lives, and therefore the FDA and HHS has taken many steps, even requiring manufacturers to produce annual summaries and certification training, in order to assure that consumers are receiving products that are reliable and safe.
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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