The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of submissions under the Emergency Use Authorization (EUA) framework. In particular, the scope of the new document covers home collection kits intended to be used to collect specimen(s) used in the context of the Coronavirus Disease 2019 (COVID-19).
Scope of the FDA Template
As stated above, the scope of the template issued by the FDA covers medical devices designed to be used to collect specimen(s) before transferring to laboratories in order to identify the virus SARS-CoV-2. It is also important to mention that the scope of the guidance covers prescription use only devices while non-prescription devices or over the counter (OTC) tests are actually falling outside the scope of the present document.
The template provides medical device manufacturers with the particular guidelines and recommendations to be taken into consideration when submitting the information and data in the course of the application for the Emergency Use Authorization – a special framework introduced by the Agency to expand and improve the availability of vitally important medical devices during the pandemic. The framework allows us to simplify and accelerate significantly the procedures related to placing medical devices on the market.
Home Collection Kit Authorization Rules
According to the template, authorization of a molecular assay could be performed in one of the following ways:
- Simultaneously with the home collection kit produced by the same medical device manufacturer – within the same authorization,
- With the separate EUA, in a case, if the home collection kit and molecular assay are being manufactured by different medical device manufacturers,
- In a form of amendment to the authorization already issued to molecular assay, providing that such amendment supplements the authorization with the home collection kit.
The FDA also emphasizes that the home collection kit placed on the market under the Emergency Use Authorization will remain authorized only during the term of validity of the appropriate EUA.
The Agency also states that the present template could be subject to changes in the FDA would find it reasonable due to the additional information related to the COVID-19 that could be obtained by the Agency later.
As mentioned in the template, the medical device manufacturers should also consult with the Pipeline and Hazardous Materials Safety Administration (PHMSA) that is part of the Department of Transportation regarding compliance with the applicable requirements on shipping medical materials.
Content of the Template
First of all, the present FDA template describes the information and data the Emergency Use Authorization submission for home collection kits shall contain. In particular, in accordance with the template, the aforementioned document shall consist of the following elements:
- Purpose of the submission. In the first section, the manufacturer shall clearly indicate the particular medical device in question by providing its name, purpose (collection only or collection and stabilization), type of specimens, and the description of the transportation element. This part should also contain the indication that the particular home collection kit should be used in the course of the molecular diagnostic testing using the in vitro diagnostic (IVD) test previously approved by the FDA.
- Information about the applicant itself, including company name, address, and other contact information.
- Proprietary and established names.
- Information regarding the regulatory clearance stating that the medical device in question has not been previously approved. This section should also contain an indication of the product code QJR.
- Proposed intended use. In this section, the medical device manufacturer shall describe the purpose the particular home collection kit shall be used for and the way it should be used by the patient. The manufacturer shall state that the medical device in question is designed to be used to self-collect particular types of specimens (that should be also clearly indicated in the submission), and also to describe the grounds why the patient should use the device. It is also important to mention that all testing should be performed exclusively by the laboratories duly designated by the manufacturer applying for the Emergency Use Authorization of the home collection kit, and also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) confirming that the laboratory is eligible to perform high complexity tests. Another important point is that the laboratory shall use only the tests authorized to be used with the home collection kits. The home collection kit described in the submission shall be used only under the EUA granted by the FDA. This section should also include a list of special conditions, namely: (1) Prescription use only, (2) Professional use only, (3) EUA only, (4) IVD use only, (5) To be used by patients older than 18 years of age.
- Description of the device. In this section, medical device manufacturers shall describe in detail the design of the home collection kit and its components. This section should also contain a description of the particular method to be used to choose individuals subject to specimen(s) collection. For instance, this could be performed by filling online questionnaires. It is important to mention that since the home collection kit is a prescription-use only medical device, it should not be provided to the individual (patient) without the appropriate prescription issued by the healthcare professional. The manufacturer shall also indicate the way the individuals may request the home collection kit and also the eligibility criteria to be applied. This section should also contain information about the specimen collection control measures implemented by the medical device manufacturer to assist the patient when using the home collection kit.
- Product manufacturing. This section should contain the information regarding the way the home collection kit subject to review will be manufactured, including the details about manufacturing facilities participating in the manufacturing process, and also about the personnel engaged in such an activity. The Agency additionally emphasizes the importance of supplementing this section with the information regarding the possibility to increase the number of home collection kits manufactured, and also the maximum capacity of existing manufacturing facilities. This section should also include a detailed description of the components included with the home collection kit, indicating the name, description, quantity, and supplier of the materials for each of the components.
- The performance evaluation section should contain the information about the validation studies performed to assess the design stability of the home collection kit. Studies should cover various aspects related to the device subject to review, such as the impact of temperature.
- Information about alternative FDA-cleared products.
- Fact sheet for healthcare providers.
- Instructions for use, proposed labeling, and insert of the packages, including copies of the questionnaires developed to determine whether the particular individual should be subject to specimen(s) collection.
- Reporting and record-keeping
In order to make COVID-19 tests immediately available to the accredited pathology laboratories, the TGA allows the direct supply of the test kits to the laboratories.
To be eligible for this exemption, the laboratory should be accredited by the National Association of Testing Authorities (NATA). This special framework also has certain limitations, namely:
- The scope of the exemption covers only the direct supply of COVID-19 test kits to the accredited pathology laboratories. In order to be allowed to distribute test kits, a medical device manufacturer or importer shall submit an application for inclusion of the device in question to the national register (ARTG).
- In order to be eligible for the emergency exemption, medical device manufacturers and importers shall comply with the special requirements set forth in the appropriate regulation.
It is also important to mention that some of the sections should be completed by the FDA. For example, the Agency intends to complete the “Unmet need addressed by the product” and “Benefits and risks” sections.
Summarizing the information described hereabove, the present FDA template provides medical devices manufacturer with the in-depth review and recommendations regarding the information to be included in the Emergency Use Authorization submission for the prescription use only home collection kit intended to be used in the context of the COVID-19 outbreak.
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