Rep. Marsha Blackburn (R-Tenn) plans to reintroduce the SOFTWARE Act, a bipartisan bill that would establish a new regulatory framework for health information technology, early next year. Blackburn announced the news at a Bipartisan Policy Center event yesterday.
"In 1938, Congress passed the Federal Food Drug and Cosmetic Act, which gave authority to the FDA to oversee the safety and efficacy of...
Six US senators sent the FDA a letter this week to check in on the agency's interactions with mobile health app developers since it published its final guidelines for mobile medical app regulation last year. The senators who signed the letter -- Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr -- stated that they wanted to ensure the agency's oversight over...
By Bradley Merrill Thompson
This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation.
Current...
There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps.
When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received...
