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.