The document summarizes current applications for tracking COVID-19 around the world and discusses regulatory requirements for such applications. It outlines several prominent COVID-19 tracking tools used by countries like Australia, China, India, UK, Germany and USA. It also discusses the FDA regulatory process for medical devices and software-as-a-medical device (SaMD), including requirements for registration, clinical testing, labeling, quality management and reporting issues. The document emphasizes that COVID-19 tracking applications must comply with FDA regulations to be legally marketed in the US.

1. A Survey on Current Applications for Tracking COVID-19
By: Govind Yatnalkar
The COVID-19 pandemic is still creating headlines in the health care domain. Around the
world, governments, and organizations such as World Health Organization (WHO), European
Medical Agency (EMA),andFDAareworking togethertoeliminatelockdownsandgetour society
back up and running. In such cases, several companies, firms, and universities have found
opportunities to provide critical services such as virus detection, tracking, data-driven decision-
making algorithms, and visual analytic applications. Based on our research for proximity tracking
applications, we were able to identify a couple of state-of-the-art COVID-19 tracking tools.1 Most
of these tools are Bluetooth based and have certain specific characteristics which distinctively
differ them from one another.
CovidSafe, the application from Australia, starts proximity data recording if a person is
within a radius of 1.5 meters of another person for more than 15 minutes. China’s tracking app
uses the QR codetechnology witha risk-basedmulticoloredvisualanalysis.India’s“AarogyaSetu”
recommends measures based on risk computation methods when users are found in contact with
a positively identified COVID-19 case. The models followed by the UK, Germany, and the USA,
which focus on user data preservation and security are getting adopted by almost all the countries
in the world. CovidWise, an application developed by Apple and Google, uses anonymous tokens
via Bluetooth Low Energy (BLE) technology to avoid storing user sensitive data. Also, it alerts all
users who are found to be in contact with a positive case token within the last 14 days.
From an FDA perspective, such applications may fall under the categories of SaMDs,
SiMDs, Digital Medicine/Health, or simply a medical device. Surely, they must be compliant with
FDA’s regulatory requirementstobe utilized in a commercial,medical,orindustrialenvironment.
These applications or devices undergo regulatory measures that not only grade their quality and
safety levels, but also test the implemented security methods.2 As these devices host a large
amount of critical and sensitive patient data, the security methodologies must meet FDA/EMA
accepted security protocols such as ISO/FDIS 81001-1 - Health software and health IT systems
safety, effectiveness, and security — Part 1: Principles, concepts, and terms.
While regulating a medical application (web/mobile-based) or a device, especially in the
USA, the FDA steps in to investigate the applied regulatory measures. FDA has provided a
1 Seerat Chabba (April 2020).Coronavirus Tracking Apps:How Are Countries Monitoring Infections?
Retrieved on 22/08/2020 from https://www.dw.com/en/coronavirus-tracking-apps-how-are-countries-
monitoring-infections/a-53254234.
2Bernard Marr (June 2020).Why Contact Tracing Apps Will Be the Biggest Test Y et ofData Privacy
Versus Public Safety.Retrieved on 22/08/2020 from
https://www.forbes.com/sites/bernardmarr/2020/06/01/why-contact-tracing-apps-will-be-the-biggest-
test-yet-of-data-privacy-versus-public-safety/#4de726da4da2

2. guidance document which offers a view of high-level activities to be conducted from a device
regulatory requirements perspective:
 Establishment Registration and Medical Device Listing – Manufacturers register
their devices with FDA and list their device they are marketing under 21CFR§807.
 Investigational Device Exemption (IDE) requirements – Enables the
investigational device to be utilized in a clinical study which collects safety and
effectiveness related data to support a Premarket Notification 510k or a Premarket
Approval.
 Labeling requirements – Verify that the device complies with corresponding labeling
regulations found in 21CFR§801 for medical devices and 21CFR§809 for in vitro
diagnostic products.
 Premarket submission for approval or Clearance – Identify the device class.
Prepare and submit an appropriate premarket submission to the FDA.
 QS or Quality System Regulation - A framework manufacturers follow to ensure that
their devices always meet applicable requirements and specifications as a part of QS
regulations (21CFR§820.30).
 MDR or medical device reporting – MDR regulation mandates manufacturers to
submitreports whenthey learnthattheirdevicehasmalfunctioned orhascauseda serious
injury or a death.
 Correcting Problems along with corrections reporting to FDA – Manufacturers
may take essential actions to upgrade the software to fix an error or bug. Under
21CFR§806.10, manufacturers are required to report these changes within 1o working
days from the time the patch or the correction is applied.
Hence, to market a medical app or a device, it is necessary to have approval from a
regulatory governing entity such as the FDA. Do you have a COVID-19 related software or a
medicaldevice thatneeds FDAapproval? Ourregulatory expertsatEMMAInternationalcanhelp
get your product compliant with FDA’s regulatory requirements. Contact us at 248-987-4497
or info@emmainternational.com for additional information.