August 1, 2014
Kinsa's smartphone-connected thermometer
The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their...
November 11, 2013
By Bradley Merrill Thompson
More than three years have passed since I wrote the first edition of this e-book for MobiHealthNews, and much has changed. Among other things, FDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content...
September 23, 2013
PillPhone: One of the first patient-facing mobile apps to get FDA clearance.
Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't.
After more than two years since the FDA first published its draft guidance on how it regulates...
May 1, 2013
By Bradley Merrill Thompson
As I said in the prior post, this series is for two types of companies: (1) those that are merely dipping their toes into mHealth because they’re afraid of the water, and (2) those that are diving right in head first with no idea how deep the water is. Both types of companies might be making mistakes, either by letting good opportunities go by or by incurring undue...
March 19, 2013
We are live blogging old school today: Hit the refresh button every few minutes for updates! (Live blog is now concluded.)
12:24PM: Rep. Ellmers very quickly concludes the hearing. That's a wrap! Next hearing is slated for tomorrow at 10AM ET.
12:22PM: Rep. Ellmers asks if medical device tax will hamper innovation. Thompson, Dagi, and Ford all said yes. Others said unclear. Rep. Ellmers says she...
May 29, 2012
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)...
March 2, 2011
Last April we published a list of "five must-read mobile health reports" that were free to anyone to download. The list was an instant hit and in recent weeks I have had requests from a number of people for a refreshed list. As of March 2011, there have been four free, must-read mHealth reports by my count -- and together they do a fine job of encapsulating a good portion of the mHealth...
January 20, 2011
In an opinion piece published in the Wall Street Journal this week, US President Barack Obama wrote that the US Food and Drug Administration (FDA) is set for reform: "Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster," President Obama wrote Tuesday.
The next day...
December 29, 2010
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental questions: (1) what mHealth hardware and software will FDA regulate and (2) if a product is regulated, to what degree? The Coalition...
July 14, 2010
If you have been following MobiHealthNews’ series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is one of the sector's biggest barriers.
As we reported earlier this year, Thompson and Dane Stout, Executive Director of the Anson Group, have formed a “temporary” mHealth...