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Consequences of the 21st Century Cures Act - State of Play

Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.

21st Century Cures Act in December 2016

To begin, we've had the 21st Century Cures Act, with Section 3060 "Clarifying medical software regulation". This is the top-level document as it is regulation voted by the Congress in December 2016.
This Act was published after guidances on general wellness, mobile medical apps, and PACS and MDDS had been published in 2016. They are in final status, but when you download these guidances, the first page contains now an additional cover page stating that these guidances have to be revised.

Guidance on Section 3060 of the 21st Century Cures Act

To do so, the FDA published in December 2017 a draft guidance titled "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act". This is a guidance on how other guidances will be revised (you follow me?). We call it Section 3060 guidance in this article.
This guidance is organized by software functions, rather than types of platforms. This is to stress that software shall be qualified as medical device, based on its functions, not the platform. For example, the same function present in an mobile app or a web site will have the same regulatory status.

The Section 3060 guidance is good news, many software functions are removed or are confirmed to be outside the scope of medical device definition. The functions below are NOT medical devices:

  • Laboratory Information Management Software (LIMS),
  • Electronic Patient Records (EHR) management systems,
  • Patient Health Records (PHR) management systems,
  • Medical Image Storage systems, such as Radiological Information System (RIS),
  • Medical Image Communication systems, and
  • Medical Device Data Systems (MDDS),

Provided that they don't offer functions in the scope of medical device definition, such as aid to diagnosis.

Note also that there is a footnote on Medical Image Communication devices in the guidance. Some devices will continue to be regulated as medical devices.

The Section 3060 guidance is also good news for software generating notifications and flags when a value is outside a range, like telemedicine or remote surveillance applications. Provided that these notifications don't require immediate clinical action, the FDA doesn't intend to enforce regulations.
Usually, when immediate clinical action is required, such software functions are named alarms and active patient monitoring.

The Section 3060 guidance is finally good news for a subset of wellness devices in the grey zone: those with functions for the management of a healthy lifestyle, while addressing chronic diseases or conditions. The FDA doesn't intend to enforce regulation on such devices either.

Comparison with European guidance

The Section 3060 guidance contains a section on software functions for transferring, storing, converting formats, displaying data and results. The wording used to name these functions is close to the one used in the European guidance MEDDEV 2.1/6 of July 2016.

The MEDDEV uses the terms storage, archival, communication, simple search or lossless compression. This is equivalent to transferring, storing, converting formats in the FDA guidance. The FDA uses converting formats, which has a broader meaning that lossless compression in MEDDEV guidance. This can be interpreted as: the medical device definition in European regulations exclude medical data conversion unless information is lost during conversion.
For the wording displaying data and results present in the Section 3060 guidance, there is the same approach in the Meddev guidance: as long as software is not used for diagnosis or treatment, such as functions displaying data to a technician, to verify that data are present, it is not a medical device.

Thus, we have a kind of convergence between the FDA guidance and the European guidance on qualification of software as medical device.

Work in progress

This guidance is still work in progress. First, it is a draft guidance. Second, the guidance refers to other guidances work in progress:

  • The draft guidance on Clinical Decision Support Software (will be the subject of a future blog post),
  • A future guidance on multi-functionality software combining medical device and non-medical device functions (there's an old post on this subject),
  • A future guidance on Medical Image Communication systems.

The section 3060 guidance is really good news for many software editors in the field of medical data management on the one hand, and wellness or healthy lifestyle on the other hand. Even if it is a draft guidance, things shouldn't radically change in the final version. The 21st Century Cures Act doesn't give much space to interpretation.

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