Could Radiation Exposure Recommendations Affect an Impending App Guidance?

Posted 08 August 2012 By Alexander Gaffney

The US Food and Drug Administration (FDA) may be in the midst of increasing cellphone use by developing its mobile medical application guidelines, but at least one government agency and a US legislator are calling for additional research on the effects of radiation emitted from the phones themselves.

In a 24 July report released by the Government Accountability Office (GAO), the government's internal program watchdog, the agency said a reassessment of the effects of radio-frequency (RF) energy exposure was in order. GAO did however caution that current research has been unable to demonstrate "adverse effects" from RF, but said both current research methods and new research may warrant a "reassessment" of evidence.

GAO said the Federal Communications Commission (FCC) had not asked federal health agencies, including FDA and the National Institutes of Health (NIH), for a reassessment of the potential risks of the radiation.

"FDA is responsible for carrying out a program designed to protect public health and safety from electronic product radiation," notes GAO in its report.  "FDA does not review the safety of all radiation-emitting electronic products, such as mobile phones, before they are marketed. However, FDA has the authority to take action, such as requiring manufacturers to replace or recall mobile phones that are shown to emit RF energy at a level that is hazardous."

Could New Findings Affect Mobile Medical Applications?

The questions have the potential to affect the assessment of mobile medical applications-an emerging classification of software-based medical devices run on mobile devices. Also referred to as "apps," the devices are the subject of a 21 July 2011 draft guidance by FDA.

That draft guideline, Draft Guidance for Industry and FD Staff-Mobile Medical Applications, notes, "Mobile medical apps may pose additional or different risks due to the unique characteristics of the platform." Though agency regulators go on to describe the impact of screen size and a person's ability to see the information provided upon it, FDA notes it, "Intends to take these limitations into account in assessing the appropriate regulatory oversight for these products."

Presumably, such a limitation could include a mobile device with a design insufficient to protect its user from exposure to dangerous levels of RF, should such a level exist.

GAO notes "FDA and others" found no compelling evidence to support the hypothesis that RF represented a safety hazard to consumers, though FDA did call for additional research on the subject in 2001. GAO now says additional research should be conducted in light of limited evidence from a retrospective review that some cancerous tumors may be associated with the use of cellphones.

At least one US congressman jumped on the report. Rep. Dennis Kucinich (D-OH) on 6 August introduced The Cell Phone Right to Know Act to introduce warning labels on cellphones regarding RF radiation and create a national research program to study the issue.

Consumers, "Deserve to have up-to-date exposure standards that are put together by health professionals without conflicts of interest," said Kucinich. The congressman said the warning labels required by his bill would contain the RF radiation emitted by the phone, the legal limits for the device and ways to further reduce exposure. The GAO report notes the way a phone is used, particularly if it is held up against the head, may increase one's exposure to RF radiation.

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Categories: FDA

Tags: Cell Phone, RF, Radio-Frequency, Mobile Medical Applications, Radiation, Latest News, GAO

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