Mobile applications that support COVID-19 self-tests are regulated by the Food and Drug Administration (FDA). The FDA communicates the requirements of the regulation during the submission and review process.
RADx MARS helps to address one of these requirements, namely data harmonization, capture, transmission, and reporting. Below we provide draft language that can be used by application developers to address this one component in their FDA submission. While this language has been reviewed internally, it is not endorsed by the FDA.
Draft language for FDA submission of mobile application that supports COVID-19 self-tests to address the component of data harmonization, capture, transmission, and reporting.
FDA Review Team:
{Company name} has built a mobile application named, {Application name} to meet FDA post-market requirements for results collection and reporting of its {Test name} test that has obtained emergency use authorization (EUA).
The application conforms to NIBIB RADx® Mobile Application Reporting through Standards (MARS) specifications as posted on the RADx MARS website, referenced on {date}. These specifications describe a standardized COVID self-test results encoding schema using HL7v2. They additionally describe a receiving data hub that relays messages to HHS Protect and if indicated, to appropriate state health systems.
The application will support the user in performing a test in the following ways: {Describe}
After the test has been completed, the application offers the user the choice to report the test result to public health systems. If the user declines, no report will be submitted. Data elements to be submitted in the HL7v2 messages in anonymous and identified reports are described in the table below.
We have confirmed the validity of our HL7v2 messages in the following way(s): {Describe and provide supporting documentation}
The hub to which we will be sending messages is: {Describe and provide supporting documentation}
We will continue to monitor the RADx MARS website for updates to the specifications and update our systems as needed. Furthermore, we will monitor the development of the FHIR specifications, looking towards future implementations of FHIR in test results reporting.
| Column 1 All reports, required. |
Column 2 |
|---|---|
| Test type with LOINC coding | Are you symptomatic? |
| Test result with SCT coding | Date of symptoms onset |
| Test date | Sex |
| Device identifiers,including test manufacturer and test name | Race |
| Specimen source with LOINC coding | Ethnicity |
| Internal specimen ID | Name |
| Zip code | Date of birth |
| Age | Address |
| Internal patient ID | Phone |
