Devices

Cell Phone Safety Limits Remain ‘Acceptable’: Shuren

CDRH director Jeffrey Shuren says FDA is “confident that the current safety limits for cell phone radiofrequency energy exposure remain acceptable for protecting the public health.” Shuren issued a statement to comment on findings from research conducted by the National Toxicology Program that found “clear evidence” of carcinogenic activity in rodents exposed to radiofrequency energy.

Shuren said the study looked at the effects of exposing rodents to extremely high levels of radiofrequency throughout the entire body. “Doing this was intended to help contribute to what we already understand about the effects of radiofrequency energy on animal tissue,” he said. “In fact, we only begin to observe effects to animal tissue at exposures that are 50 times higher than the current whole body safety limits set by the FCC for radiofrequency energy exposure.”

The statement also cites a National Toxicology Program statement that its “findings should not be directly extrapolated to human cell phone usage.” Shuren said FDA agrees that the findings should not be applied to human cell phone usage.

“As part of our commitment to protecting the public health,” he concluded, “FDA has reviewed and will continue to review many sources of scientific and medical evidence related to the possibility of human health effects from radiofrequency energy exposure in both humans and animals and will continue to do so as new scientific data are published. Based on our ongoing evaluation of this issue, the totality of the available scientific evidence continues to not support adverse health effects in humans caused by exposures at or under certain radiofrequency energy exposure limits. We believe the existing safety limits for cell phones remain acceptable for protecting the public health.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome