iThis year is set to bring several important developments from Congress and FDA relating to FDA regulation (or deregulation) of software, including mobile apps. FDA has recently issued several draft and final guidances in this space and Congress has circulated several draft bills. Most recently, the House Energy and Commerce Committee released a discussion draft of the 21st Century Cures Act, which includes proposed legislation relating to health and medical software. A brief summary of this legislation and other important developments are provided below.
First, a brief recap of the major developments in recent years related to software:
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Cybersecurity Guidance. On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.
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Health IT Report. FDA (together with other federal agencies) issued this report in April 2014, which outlines a proposed strategy and recommendations on a risk-based regulatory Health IT framework.
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Mobile Apps Guidance. On September 25, 2013, FDA provided industry with some clarity regarding how FDA intends to regulate mobile apps in the Mobile Apps Guidance. This guidance was updated by FDA on February 9, 2015, to be consistent with the recently issued MDDS Guidance (see below for a description of this guidance).
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Congressional Activity. Three bills were introduced in 2013 and 2014 to clarify the scope of FDA’s authority to regulate Health IT – the PROTECT Act and the MEDTECH Act were introduced in the Senate in 2014, and the SOFTWARE Act was introduced in the House in 2013. While none of these bills moved on the Hill, a new version of the SOFTWARE Act was introduced in the recently issued 21st Century Cures Act discussion draft.
There have already been several important developments from both FDA and Congress this year in the software space, and FDA and Congress have both indicated that more developments are forthcoming:
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MDDS Guidance. On February 9, 2015, FDA issued a final guidance titled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices” to inform manufacturers that FDA does not intend to enforce compliance with any FDA regulatory requirements for these devices.
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Draft General Wellness Guidance. On January 20, 2015, FDA issued this highly anticipated draft guidance regarding its regulation of low risk general wellness products. The draft guidance sets forth a definition of “general wellness products,” and articulates a policy under which these products will not be actively regulated by FDA. Although not solely focused on software, this guidance provides further clarification to the rapidly developing and expanding wellness products industry.
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Draft Accessories Guidance. On January 20, 2015, FDA issued a second highly anticipated draft guidance on the regulation of medical device accessories. FDA seeks to clarify and modify its policy concerning the classification of accessories in this draft guidance.
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Medical Device Decision Support Software Draft Guidance. FDA placed this important draft guidance on its “A-list” of guidances to publish this year.
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Discussion Draft of the 21st Century Cures Act. This discussion draft was released on January 27, 2015. The “Sensible Oversight for Technology Which Advances Regulatory Efficiency” subtitle of the draft bill would limit FDA authority over health information technology. This subtitle would not just change how FDA regulates “medical software,” but would also exclude “health software” from FDA regulation. Definitions are provided for both of these types of software in the draft bill. This subtitle also provides a definition of an “accessory,” which makes clear that an accessory should be classified “based on its own intended use, functionality, and risk,” instead of taking on the classification of the product with which it is used.
FDA also announced that it will be holding a webinar on February 24, 2015, to discuss the recently released MDDS Guidance, and draft Wellness and Accessories guidances.
