The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a transcript of the virtual town hall dedicated to the guidance on Coronavirus (COVID-19) diagnostic tests issued earlier by the Agency. The conference was hosted by the representative of the CDRH`s Office of Communications and Education. Additional information was provided by the director of the Office of In Vitro Diagnostics and Radiological Health in the Office of Product Evaluation and Quality from CDRH. The conference also included the questions-and-answers section. 

COVID-19 Tests in Brief

The present virtual town hall conference was dedicated to the tests intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.” In accordance with the current legislation, these tests are subject to regulation as in vitro diagnostic medical devices. 

First of all, it was mentioned that in order to be allowed for marketing and use in the US, both antigen and molecular tests should be duly approved by the FDA in accordance with the appropriate procedure set forth by the applicable regulations. At the same time, the Agency is not going to object to the off label use of the FDA-approved tests for asymptomatic screening. This relates to all antigen tests allowed to be marketed and used. 

It was stated that the highest accuracy and reliability of the results could be achieved by using the molecular tests. For sure, there is an option to use another antigen test to get a confirmation of the results, but in any case, the accuracy and reliability of molecular tests are significantly higher, while in the case of antigen tests there is a probability to get several false-negative results in a row in the course of the repeat testing. 

However, the actual performance of antigen tests used for the asymptomatic population is still unclear and should be subject to additional analysis. 

FDA Approach to COVID-19 Tests

It was also mentioned that the FDA expects to receive more requests for authorization of tests intended for home use of all the types, including antigen, molecular, and serology ones. The Agency additionally emphasizes the importance of the molecular tests intended to be used in the home environment. At the same, the FDA acknowledges that molecular tests are slightly more difficult in manufacturing, and consequently, more expensive. 

However, some tests are quite simple – for instance, the first home out-of-the-counter (OTC) test authorized recently by the FDA actually constitutes a piece of paper. Such tests could be easily manufactured in the amount sufficient to address the increasing demand for such tests during the COVID-19 outbreak. These tests are already available for use under the Emergency Use Authorisation – a special framework used to ensure and expand the availability of critically important medical devices.   

In other words, the Agency expects medical device manufacturers to apply for authorization of more and more tests of various types with the primary focus on the ones intended for home OTC use. 

When describing the OTC medical devices intended to be used in the home environment, it is important to emphasize the following key features of such devices:

  • They should be designed in a way reducing the possibility of incorrect use (i.e. contain design controls in the form of special elements preventing the customers from incorrect use), 
  • The use procedures should be simple enough in order for the laypersons without the appropriate qualification and experience to use them and get accurate and reliable testing results,
  • They should be supplied with detailed enough instructions for use describing the processes and procedures to be performed. Moreover, the information should be provided in a clear and understandable way.

The manufacturers of the in vitro diagnostic tests intended for home OTC use should analyze the possible way the customers may use the tests, and the results they may receive in case of incorrect use. 

Questions And Answers

The virtual town hall conference on COVID-19 tests also included a question-and-answer session during which the industry representatives had a possibility to discuss the most important aspects related to the in vitro diagnostics devices described herein with the representatives of the regulating authority. 

  1. The first question discussed during the virtual town hall conference was related to the reporting and information exchange with regard to the home OTC use tests. In particular, the industry representatives asked about the approach to be used to collect the information related to the testing performed by the customers themselves. As one of the solutions, it was suggested to develop the appropriate application that would be used to transmit the information about the testing results. The representatives of the Agency also mentioned that the application could be developed independently, without any connection with the particular COVID-19 test. In this case, a wide range of customers would be able to use it. The FDA has announced a call for submissions encouraging the software developers to provide their suggestions and already received a lot of them. 
  2. The next question discussed was related to the nasal swabs and comparators associated thereto. In particular, it was stated that a high sensitivity molecular test could be used for this purpose. The discussion also covered the aspects related to the use of retrospective samples, viral transport mediums, and bank samples. It was also mentioned that in order to be able to assess the effectiveness of the in vitro diagnostic medical device subject to review and determine whether it meets the authorization criteria, the regulating authority would need at least five positive fresh samples collected in the course of point of care testing. The study should be also continued after obtaining authorization from the FDA, during the post-marketing stage. 
  3. Another question discussed during the virtual town hall conference was related to the FDA`s policy with regard to reviewing laboratory-developed tests. In this regard, the representative of the authority stated that the question is still under development. 

The FDA representatives stated that the Agency will continue virtual town hall conferences in order to assist industry representatives in achieving and sustaining compliance with the applicable requirements. In particular, the Agency intends to provide the developers of both antigen and molecular tests with the possibility to get responses to the questions they are facing. 

Summarizing the information provided here above, the virtual town hall conference dedicated to COVID-19 tests covered the most critical aspects related to the development and marketing authorization of these in vitro diagnostic medical devices. The representatives of the regulating authority have provided a brief overview of the existing situation and main priorities the Agency is focused on nowadays. The industry representatives have discussed some of their questions with the FDA officials participating in the conference and received additional recommendations and clarifications. 

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