The Food and Drug Administration on Thursday said it has no plans to subject smartphones and tablets to a controversial tax in President Obama’s healthcare law.
Republican members of House Energy and Commerce Investigations subcommittee this week seized on reports that the agency could extend the healthcare law's tax on medical devices to iPhones, BlackBerrys and Android devices.
But an agency official assured lawmakers on Thursday that smartphones will be exempt from the tax.
“They would not be regulated as medical devices, therefore not subject to the medical device tax,” said Christy Foreman, director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health.
Foreman said FDA does have authority to regulate certain smartphone applications, but those reflect a fraction of the estimated 40,000 medical apps now on the market. Those applications would include apps with ultrasound technology capabilities or those used to diagnose health problems.
In short, any app that could pose a health risk to users if not properly used could fall under regulatory scrutiny, she said. Calorie counters or pedometers would not make that list, she said.
Rep. Henry Waxman (D-Calif.), the full committee’s top Democrat, lambasted Republicans on the panel for wasting time on a “non-issue.”
“There are too many pressing issues before us for the committee and this Congress to get bogged down for three days in what amounts to an inaccurate talking point about FDA overregulation and a nonexistent iPhone tax,” he said.
Even if the agency listed smartphones as medical devices, they could still avoid the medical device tax under an exemption in the law for retail products, Waxman said.