FDA finally issues proposed rule simplifying medical device classification

The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.)  In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).  

As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure.  (more…)

A very Appy week!

Although my fellow editor Chrys has done a great job of covering the Ofcom-sponsored report on attitudes and behaviours of apps users, and The Boss (aka Donna) has highlighted the HIMSS Analytics Mobile Study as well as covering the opposition to the PROTECT legislation, identifying a tax issue that might just be behind it all, there is still more to report on the apps front this week.

Beginning with that PROTECT legislation, the same Brad Thompson that Donna quotes also writes in Mobihealthnews of the recommendations of the FDASIA committee on how the FDA can improve the regulation of mobile health. The overall recommendation is that the “FDA needs to do a better job at (more…)