The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued the Emergency Use Authorization (EUA) with regard to the in vitro diagnostic devices (IVDs) intended to detect antibodies to the virus SARS-CoV-2 or the “novel coronavirus” to be used in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19).
IVD Emergency Use Authorization in Brief
The scope of the present FDA authorization covers the SARS-CoV-2 Antibody Test already assessed and validated by any government agency duly designated by the FDA, providing that such devices meet the criteria described therein. The devices of this type are being used to identify an adaptive immune response to virus SARS-CoV-2 to identify the patients that have been infected by the aforementioned virus. It is also important to mention that the scope of use provided by the authorization covers only the laboratories duly authorized in accordance with the applicable legislation. Thus, to be eligible to use the devices subject to the present EUA, the laboratory should be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), providing that the scope of its certification covers moderate or high complexity tests.
In order to be able to benefit from the EUA, the manufacturer of the device falling within the scope of authorization shall submit an appropriate request to the Agency, and the Agency shall explicitly confirm that the device in question meets EUA requirements and could be used under the present EUA.
Grounds for the EUA Implementation
The present EUA is based on the public health emergency announced in February 2020, and on the national emergency related to the COVID-19 pandemic announced in the US later in March 2020. In these circumstances, the Agency intends to implement additional measures reasonably necessary to expand the availability of the medical devices used in the context of the COVID-19 outbreak. In particular, the devices falling within the scope of the guidance are admissible for the EUA due to the following points:
- The virus the devices are being used to identify could cause serious diseases, including respiratory illnesses;
- The authorized devices confirmed their effectiveness for the purpose of the detection of the immune response to the aforementioned virus;
- The authorized devices have no alternative available among the devices already approved and cleared by the FDA.
Scope of Authorization
The particular scope of authorization covers the in vitro diagnostic medical devices explicitly stated therein, providing that such devices are being used only in the duly certified laboratories for the purpose of identification of the immune response to the novel coronavirus by detecting antibodies (such intended purpose should be specified in the instructions for use for any medical device subject to authorization).
To determine the admissibility of the particular medical device for the Emergency Use Authorization, the Agency utilizes a set of criteria related to the performance and labeling of the device in question. When making a decision regarding the authorization, the FDA considers the following criteria:
- Independent Clinical Agreement Validation. The medical device manufacturer applying for the EUA shall provide the Agency with the data deriving from the independent validation study. The results of the study should be based on the evaluation of at least 30 positive and 80 negative antibody samples respectively. The FDA also states that ten of the negative samples used for evaluation should be HIV positive. The study data shall demonstrate at least 90% accuracy for positive samples and 95% accuracy for negative ones.
- Validation Performed by the Manufacturer. If the device is intended to detect IgG and IgM, the manufacturer shall provide the reports confirming that the device in question detects IgG and does not cross-react with IgM and vice versa, as well as any additional test data supporting the features and performance of the device claimed by the manufacturer.
- Labeling Criteria. The labeling of each in vitro diagnostic medical device subject to the FDA authorization under the emergency use pathway described herein should contain the following information:
- The intended use of the device, including the particular antibodies the device is intended to identify (e.g. IgG, or IgG and IgM).
- The indication that the device should be used only under the EUA.
- The statement that the negative results provided by the test do not guarantee the absence of the virus.
- The statement that false positive results may occur from time to time due to certain reasons.
- The detailed instructions for use, including the interpretation of the results.
- Additional limitations to be considered when using the device, including the potential impact the deviations may have to the results, and also the indication that the device should not be used as a sole basis for making decisions by healthcare professionals regarding the diagnosis or treatment.
- All study results available, including ones related to the studies performed by the manufacturer.
- The information about the manufacturer of the device, including its contact details.
- The date the instructions for use were created.
In a case the device subject to evaluation meets any and all criteria described hereabove, the Agency adds the device to the appropriate list of the in vitro diagnostic devices subject to authorization, and also provides the manufacturer applying for authorization with the appropriate letter confirming that the EUA shall be applied.
Application Procedure in Detail
In order for the medical device to be added to the authorization list, the manufacturer of the device should submit the appropriate application (request) to the FDA. The request for authorization of the in vitro diagnostic device under the Emergency Use Authorization framework should include the following elements:
- The information about the manufacturer, including its name, actual address, email address, and other contact information, and also the information about the device in question, including the brand name and model number. In the case of foreign medical devices, the information submitted shall also include the details on the local US representative of the manufacturer and marketing authorizations granted to the device in the country of origin.
- The sample of the labeling of the device, providing that it meets the appropriate labeling requirements described hereabove.
- The information on any foreign marketing authorization the device already has, including the number of the appropriate certificate.
- The indication of compliance with the ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes).
- The information necessary to confirm compliance with the applicable criteria.
The device authorized by the FDA under the EUA pathway could be used by the certified laboratories when performing the appropriate examinations. The device should be properly accompanied with the all necessary information, including the indications and instructions for use, the labeling that meets the requirements set forth by the present regulation, and also the indication of the Emergency Use Authorization stating that the device is intended to be used only under the EUA framework.
Summarizing the information provided hereabove, the FDA describes the approach to be applied for the tests intended to detect the antibodies indicating the immune response to the virus SARS-CoV-2 during the public health emergency associated thereto.
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