Forty years is a long period of time, but that is about how long it has been since the Food and Drug Administration (FDA) last updated its rules and regulations regarding the approval of new medical devices. The agency is now looking to modernize the way in which it gives approval for new medical devices after an investigative report suggested that over 1.7 million individuals were injured and over 80,000 additional people were killed as a result of medical devices that had been reported to the FDA.
One of the most significant proposed changes to the approval process would require medical device manufacturers to compare their proposed devices with other approved devices that are more current and that feature updated safety features. In the past, manufacturers of medical devices may have been able to obtain approval for devices by comparing their devices with ones that had been approved decades previously.
Defective and dangerous medical devices are a scourge on the healthcare industry and the lives of patients who are injured by them.
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