Medical devices rely on proper use to be "safe and effective"
by StevenWiens
Wednesday, October 3rd, 2007
Medical devices rely on proper use to be "safe and effective," which is why FDA has in recent years encouraged devicemakers to incorporate human factors engineering into their development processes. What is human factors engineering (or HFE)? FDA defines the term, simply, as the "application of human factors principles to the design of devices and systems." HFE is accounting for how users interact with a device, and the process of identifying operational or label issues that may prevent the device from being used as intended. FDA often requires that human factors data be included in premarket submissions, or the data may be reviewed in postmarket scenarios in response to a serious adverse event. Read the article ...
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One of the few device-specific examples cited in the letters, sent to members of Congress, FDA leadership and President Obama, disclosed a decade of disagreement between radiological branch reviewers and ODE management over the approval of computer-aided detection devices for imaging analysis.
The agency does not dispute there are disagreements, but stresses that the office move results from broader regulatory concerns, rather than personal strife.
"Just because you have disagreements doesn't mean you necessarily change around your structure," said Peper Long, an FDA spokeswoman. "But in this case, the OIVD structure was a natural fit for the diagnostic nature of radiology devices.
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