My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on ...

The following examples represent mobile apps FDA considers "mobile medical apps" under the narrow definition it outlined in the draft regulatory guidelines it published this morning. The FDA is ...

CDRH intends to finalize its draft guidance on mobile medical applications by the end of the year, according to Center senior policy advisor Bakul Patel. During a radio interview on The Federal Drive ...

Mobile applications, commonly referred to as “apps,” can be enjoyed with just the touch of a screen and are often effortless to download. However, the Food and Drug Administration’s (FDA) current ...

In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory ...

Here's a look at how to make sure you're jumping through all the right regulatory hoops to bring your mobile medical app to market. iPhones are the new medical device. It’s true. Every time I login to ...

Potentially deadly mathematical errors are prevalent among mobile applications used in clinical and emergency room settings, but a team of researchers at New Jersey Institute of Technology's Ying Wu ...

If you include the words "US Food and Drug Administration" (FDA) and "Social Media" in the same sentence, it is generally followed by an explanation of how the former has failed to issue guidance on ...

Every day clinicians incorporate clinical knowledge, skill, and experienced practice to provide care for their patients. Another valuable tool has the potential to dramatically change patient ...

The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient’s safety if they do not function as intended. Some of the risks ...