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FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

mHealth mobile phoneNearly two years after first setting out its planned approach to the regulation of medical smartphone apps, the FDA said last week final guidance will be ready “in [the] coming weeks”.

The US regulator wants oversight of mobile apps that do the job of a medical device, either by transforming a mobile device into a medical device it already regulates, or by acting an accessory to a FDA-regulated medical device.

Writing on the FDA Voice blog the director of the FDA's Center for Devices and Radiological Health, Office of Device Evaluation, Christy Foreman offered several examples of mobile technology the FDA will seek to regulate.

They included smart phone that performs an ECG - such as the AliveCor Heart Monitor the FDA approved last year - and apps that control the delivery of insulin, act as a stethoscope or provide clinicians with radiation dosage calculations.

Foreman said the FDA has “a public health concern” about what it terms “mobile medical apps” and the potential consequences should they malfunction, but added that “only a fraction of mobile apps” would fall into this category and therefore require FDA review”.

Foreman last week appeared at a Congress hearing on health information technology, where she outlined the FDA's plans list FDA-approved apps on a publically available website.

This site would also show which apps the FDA “intends to exercise enforcement discretion, in order to provide continuing clarity on this issue for industry and other stakeholders,” she told the House Energy and Commerce Committee.

She also denied the FDA had any intention of stifling innovation, as suggested by Republican leaders of the Committee when they wrote to FDA Commissioner Margaret Hamburg earlier this month.

“FDA recognises the importance of implementing a balanced, transparent approach that fosters the development of health IT solutions and innovative products like mobile medical apps, while ensuring appropriate patient protections.

“Like traditional medical devices, mobile medical apps may in some cases present significant health risks to patients. FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended,” she said.

Although two years seems a long time between draft and final guidance, it bests the FDA's 2009 social media hearing, which has yet to produce even draft guidance.

In addition, the House Energy and Commerce Committee's interest in the area could ensure the FDA make good on its pledge to quickly finalise guidance.

25th March 2013

From: Research, Sales, Marketing, Regulatory, Healthcare



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