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New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • April 5 2017

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman

New European MEDDEV Guidance on Stand-Alone Software
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • July 28 2016

On 15 July 2016, the European Commission published a new version of its medical devices guidance, known as MEDDEV, on the qualification and

mHealth in the UK: mobile health is on the move - part 1
  • Penningtons Manches LLP
  • United Kingdom
  • August 14 2015

It is predicted that by 2017 3.4 billion people worldwide will own a smartphone and half of them will be using mobile health applications (mHealth

The FDA releases long-awaited final guidance on mobile medical applications
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • September 24 2013

On September 23, 2013, the U.S. Food and Drug Administration (the "FDA" or the "Agency") issued long-awaited final guidance for developers of mobile

FDA to host public workshop on mobile medical apps guidance
  • Kelley Drye & Warren LLP
  • USA
  • August 18 2011

The FDA announced that it will host a public workshop on September 12th and 13th, 2011 to gather input on the agency’s recently issued draft guidance document, “Mobile Medical Applications.”

Your software may be a ‘medical device’ subject to FDA regulation
  • Fish & Richardson PC
  • USA
  • August 10 2011

In late July 2011, the FDA released a draft guidance document outlining when certain types of software would be considered a “medical device” subject to FDA scrutiny.

Second in series: FDA draft guidance - mobile medical apps: cheat sheet
  • McGuireWoods LLP
  • USA
  • August 3 2011

FDA has decided to regulate mobile medical applications (MMAs) that are either for an intended use that has traditionally been considered a medical device, or affect the performance or functionality of a currently regulated medical device.

Is your smart phone an FDA-regulated medical device?
  • Jones Day
  • USA
  • August 3 2011

An enormous number of software applications have been developed for use on handheld computers such as smart phones, tablet computers, and personal digital assistants.

FDA issues draft guidance on mobile medical applications
  • King & Spalding LLP
  • USA
  • August 1 2011

The U.S. Food and Drug Administration (FDA) recently released its “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications.”

New FDA draft guidance on mobile medical apps provides some clarity, but raises many more questions
  • Morgan Lewis
  • USA
  • July 28 2011

On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications, describing FDA’s position on the regulation of mobile applications, i.e., software applications intended to run on mobile platforms, such as smart phones, personal digital assistants, tablets, and other mobile computing devices.