US Lawmakers Seek Regulatory Exemptions for Some Mobile Medical Devices and Apps

Separate proposals in each chamber of Congress would end FDA regulation of “clinical software” and “health software” in order to support innovative developers in a burgeoning industry (according to lawmakers) that moves “faster than the existing regulatory approval process.”  The House and Senate bills distinguish between “medical software,” which would remain under FDA oversight, and clinical and health software, redefined as follows:

• Clinical Software:  clinical decision support software used to capture, analyze or manipulate clinical data in order to recommend any clinical action, and is for use only by healthcare providers.
• Health Software:  any software used to capture or analyze clinical data, support administrative functions or serves as a platform for secondary software.

The FDA would retain authority for software and devices used by consumers to directly diagnose conditions; that analyzes radiological or imaging data for diagnostic purposes; or that serves as a direct component or feature of a medical device.

So which types of mobile medical devices, apps and software would no longer fall under FDA requirements?  According to an analysis by, quite a few—including high-risk clinical decision support software not well understood by lay users; consumer-use melanoma apps; drug- and radiation-dose calculators; consumer-use disease managers; and hospital patient monitoring software, for example, would be excluded from current FDA medical device regulations.

Like ongoing US Medical Device Excise Tax repeal proposals, these bills appear to boast bipartisan support, particularly among legislators whose states have robust medical device and technology industries.  But as they are currently written, the bills’ distinctions between what does and does not constitute “medical software” are dangerously broad.

REFERENCE:  Emergo Group; Stewart Eisenhart; 6 FEB 2014

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