The latest draft guidance from the FDA is about communications surrounding safety signals from devices in market.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:
- Emerging signals that apply to software can be a couple of types:
- New adverse events associated with the device or the reporting patterns around known events
- Patient injuries or reduction of benefit, which could possibly include the indicate of tests not needed or declining effect of behavior modification effects over time
- The FDA is considering the information already in the public domain when deciding what to communicate about a device, and they consider all sources such as “mainstream or social media.” They are also willing to counteract misleading information if a group decides to spread false information:
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:
- General Wellness Products
- Medical Device Accessories
The list also includes:
- Adaptive Design for Medical Device Clinical Studies
- Applying Human Factors & Usability Engineering to Optimize Medical Device Design
As for the often more interesting draft guidances, the ranked list includes some topics important for mobile medical app developers:
- Medical Device Decision Support Software
- 510(k) Modifications
- Software Modifications
- Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices