As expected, the third and final (for now, at least) congressional hearing focused on the FDA's regulation of mobile medical apps was the only one that provided new information for those already well-versed in mobile health. While the past two days of testimonies likely helped members of Congress better understand the concerns of those working or lobbying for the healthcare and technology...
Much has been written in the past few weeks about Congress' efforts to put its mark on the FDA's regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a...
By Bradley Merrill Thompson
Mobile apps seem all the rage in the pharmaceutical industry. According to the website InPharm, there are presently over 100 of them publicly available. Based on what I'm hearing from pharmaceutical companies directly, that's only a small number compared to the apps in development.
Recently there's been a debate going on in the UK about whether pharmaceutical apps are...
Photo Credit: Paul Savage Photography
By Padma Nagappan
One of the panels at the recently concluded WLSA Convergence Summit in San Diego focused on how things have changed within the last five years and whether the guidelines the FDA issued last year for devices helps provide clarity in navigating the choppy waters of clearance.
The panel featured two companies that have received 510(k)...
The Wall Street Journal published a report last summer that questioned whether "toning" sneakers like Skechers Shape-Ups or Reebok's EasyTones really help users get in better shape. The article included two links to case studies on the respective sneaker makers' sites that touted the various fitness benefits provided by the sneakers. The sneakermakers actually asked the WSJ to update the article...
According to the FDA's mobile medical app draft regulatory guidelines, which it made public this morning, there are a handful of different types of health and medical apps that the agency specifically said would not be regulated under the proposed guidelines. Here are the descriptions of those apps that the FDA does not plan to regulate (for now):
•Mobile apps that are electronic “copies” of...
