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FDA smartphone regulation could stifle innovation

US House Republicans issue warning on guidance and call for more information

Mobile deviceUS politicians have called on the Food and Drug Administration (FDA) to provide more information about the way it intends to regulate medical smartphone apps, warning the regulator's draft guidance risks holding back innovation in the sector.

Republican leaders of the House Energy and Commerce Committee wrote to FDA commissioner Margaret Hamburg earlier this month with a series of questions, first among them: when will the FDA issue final guidance for medical apps?

The Committee, whose broad oversight includes telecommunications, food and drug safety and health services, is currently looking at how current legislation is applied to smartphone, tablet and mobile application manufacturers.

The FDA began seeking public input on its planned approach for regulating mobile medical apps as medical devices in July 2011, launching what was meant to be a three-month consultation on its draft guidance for the technology.

The regulator proposed then that it would oversee what it terms 'mobile medical apps' - those it judges could cause patients harm if they don't work as intended – but it's a potentially wide category of apps that could include disease calculator and patient data apps, two popular categories.

In its letter to the FDA, the House Committee also voiced its concern that rules on the mobile technology could encompass 'actual use' and not just 'intended use', something they say “could affect the growth and innovation in this market”.

The Committee wants to know:

• When will the FDA issue final or updated guidance for mobile medical applications designed for use on smartphones or other mobile computing devices

• Has the FDA discussed, prepared or analysed the effect of the medical device tax, mandated by the Patient Protection and Affordable Care Act, on smartphones (as well as tablets or similar devices)?

• Will the actual use of a smartphone, tablet or app be a factor in whether the FDA chooses to regulate the device or app as a medical device?

• How many mobile medical apps have sought approval from the FDA before entering the market? How many mobile medical apps have been subject to oversight by the FDA after introduction to the market?

• How many apps have either been changed or removed from the market by FDA oversight, and why?

While the FDA has approved a device that transforms an iPhone into a heart monitor and a Bluetooth-enabled blood glucose monitor, both the regulator and pharma have so far shied away from getting the expanding range of industry mobile apps certified as medical devices.

12th March 2013

From: Regulatory



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