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.