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FDA takes 'tailored' approach to mobile app regulation

Issues final guidance on smartphone and tablet computer technology

Mobile medical appsThe FDA has issued final guidance for developers of what it terms 'mobile medical apps' – smartphone apps that perform the same functions as traditional medical devices.

The US regulator said it would take a “tailored approach” to regulating the technology, which has proliferated in recent years, driven by the emergence of Apple's iPhone.

Broadly speaking, general health apps such as those that allow patients to log and track their blood pressure will not face greater scrutiny, neither will those that help people track what they eat.

The FDA said it will exercise “enforcement discretion” and not seek to actively regulate the majority of healthcare apps, which it judges pose only a minimal risk to consumers.

Instead it will focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients – those that meet the statutory definition of a device and either are intended:

• to be used as an accessory to a regulated medical device; or

• to transform a mobile platform into a regulated medical device

Such apps include those those that can be used to control the inflation and deflation of a blood pressure cuff or that use a mobile platform for medical device functions, such as to attach a blood glucose strip reader to a mobile platform to function as a glucose meter.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said: “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.

“Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

In its new guidance the FDA said the apps it assesses will be reviewed “using the same regulatory standards and risk-based approach that the agency applies to other medical devices”.

The FDA's guidance gives the following examples of apps for which it intends to exercise 'regulatory discretion' – and therefore not enforce the requirements of the Federal Food, Drug and Cosmetic (FD&C) Act:

• Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment

• Mobile apps that provide patients with simple tools to organise and track their health information

• Mobile apps that provide easy access to information related to patients' health conditions or treatments (beyond providing an electronic “copy” of a medical reference)

• Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions

• Mobile apps that perform simple calculations routinely used in clinical practice

• Mobile apps that enable individuals to interact with personal health record or electronic health record systems.

The regulator's guidance also doesn't extend its oversight to the sale or general consumer use of smartphones or tablets, neither will it regulate mobile app distributors such as the iTunes App Store or its Google Play equivalent.

The FDA said this approach would support innovation while protecting consumer safety - deflecting criticism earlier this year from a House committee that guidance risked stifling innovation in the sector.

Bakul Patel, senior policy advisor to the director of FDA's Center for Devices and Radiological Health, said: "Mobile apps are unleashing amazing creativity, and we intend to encourage these exciting innovations.

"At the same time, we have set risk-based priorities and are focusing FDA's oversight on mobile apps that are devices for which safety and effectiveness are critical."

Read: FDA guidance on mobile medical apps

This post was updated on September, 24 - my thanks to John Mack for clarifying part of the guidance 

24th September 2013

From: Regulatory



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