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Regulatory Focus™ > News Articles > 5 > FDA Begins Consultation on Software Excluded From Definition of Device

FDA Begins Consultation on Software Excluded From Definition of Device

Posted 29 May 2018 | By Michael Mezher 

FDA Begins Consultation on Software Excluded From Definition of Device

The US Food and Drug Administration (FDA) on Tuesday launched a public consultation on the benefits and risks of certain medical software excluded from the definition of a medical device under the 21st Century Cures Act.
Section 3060 of Cures stipulates that software that provides administrative support; encourages a healthy lifestyle; electronic health records; software used to transfer, store, convert or display data; and software that provides limited clinical decision support does not meet the definition of a medical device.
Cures also requires FDA to issue a report on the benefits and risks of such software by 13 December 2018, and every two years thereafter, based on feedback gathered from industry, patients, healthcare providers and investors.
FDA says the report is meant to detail “best practices to promote safety, education, and competency” related to the software excluded from regulation as a medical device by Cures.
“The Cures act reflected, and in some cases expanded, policies FDA had already begun to implement,” FDA writes, referring to its efforts to ease regulatory oversight for some software-based applications.
In December, FDA issued two draft guidances, Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, meant to clarify the agency’s role in regulating digital health products. The agency has also previously said that it does not plan to regulate certain digital health products, such as mobile apps or general wellness devices.


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