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FDA releases guidance on communicating about device safety


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The latest draft guidance from the FDA is about communications surrounding safety signals from devices in market. Since many mobile apps used in clinical practice would be considered devices under the mobile medical app designation this guidance may be important for some healthcare marketers.

The guidance is written mainly for traditional physical devices rather than software “devices” but it does touch on three topics that provide some idea of how the FDA is thinking about safety and software:

At times, the decision to communicate about a medical device emerging signal may be affected by information the public has received from sources other than FDA, such as in the mainstream or social media. In some cases, the safety of a particular medical device or type of device may be publicly questioned based on incorrect, incomplete, or misleading information. In such cases, FDA may issue a statement or engage in other methods of communication to clarify or correct information and respond to public interest.

The FDA may not be able to keep pace with modern business as they plan on “updates to the communication should be posted to the FDA website at least twice per year.” They allow for more frequent communication but a baseline of every six months is not fast enough for businesses in the digital age.

Other FDA guidance news:

The FDA’s Center for Devices and Radiological Health (CDRH) has released it’s ranked list of guidances for 2016 and the top two final guidances are:

The list also includes:

As for the often more interesting draft guidances, the ranked list includes some topics important for mobile medical app developers:

Source: FDA.gov

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