Many Medical Devices Hit the Market before Safety Studies Are Published

The FDA defines a high-risk device as one that “supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury.”

Even for the high-risk devices that were included in the current study, the research often consisted of low quality, small studies, notes Redberg, who was not involved in the new paper.

Marcus noted that while it is important to make sure new devices are safe and effective, it the approval process becomes too difficult, people might be deprived of important new medical developments.

“A careful balance needs to be struck,” he says.

Are recent controversies over metal-on-metal hip replacements and an IOM report cause for worry?

(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…

(Reuters Health)—Many high-risk therapeutic devices get U.S. Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk…

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