In an effort to determine their risk to consumers, the Food and Drug Administration (FDA) has asked companies to submit data on certain medical devices marketed prior to 1976.
FDA has asked for safety and effectiveness data for devices falling into 25 categories, including the female condom, spine products and various parts for pacemakers. Zimmer Holdings Inc., Medtronic Inc. and Johnson & Johnson's device unit, Cordis Corp. Companies are some of the companies that make devices falling in these 25 categories.
After a law was passed in 1976 authorizing FDA authority to review new medical devices, this is the agency's first step toward completing its review of devices marketed before 1976. The agency was severely criticized in January by the Government Accountability Office, a non-partisan government watchdog for taking over 30-years to complete the review. In the interim, FDA approved 200 high-risk medical devices through a process designed for low and moderate-risk devices.
Companies have 120-days to submit data, with the help of which FDA devices are classified as Class I, II or III, the last is for products that have to go through the agency's toughest review process for devices. Devices that fail to pass the review get pulled off the market, with some getting lower classifications, or they may be safe and effective enough to get through the agency's strict review process.
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