FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060 of the 21st Century Cures Act
The guidance documents, which were published Dec. 8, are not legally binding on the agency, but they are intended to provide the regulated industry insight as to how the FDA will implement and enforce section 3060. The provision itself is the culmination of a trend toward less FDA regulation of software technologies that tend to come close to, or brush up against, medical device status.
What’s particularly relevant is that Congress removed swaths of technology from the definition of a medical device, and therefore eliminated the FDA’s jurisdiction such that many software developers no longer need to meet the agency’s regulatory requirements, and perhaps more importantly, be concerned about living in the nebulous state commonly known as the FDA’s zone of “enforcement discretion.” The draft guidance documents, unfortunately, do not shed much additional light on the statutory language. Medical device manufacturers, IT companies, and software developers, therefore, should seek out qualified counsel to help them determine their status vis-à-vis the FDA and the regulatory requirements attendant to that status.
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