The Food and Drug Administration (FDA), the US regulating authority in the sphere of medicinal products and medical devices, has published an enforcement policy dedicated to viral transport media in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). The document is intended to provide medical device manufacturers, accredited laboratories, and other industry representatives with important information regarding compliance with the applicable regulatory requirements.
Regulatory Background
The scope of the present FDA guidance covers medical devices intended to be used in transporting clinical specimens including ones intended to be used with all types of SARS-CoV-2 tests, such as molecular Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) tests or antigen-detection diagnostic tests during the pandemic.
First of all, the Agency emphasizes the importance of COVID-19 tests used for case detection. It is mentioned that the FDA has already issued numerous Emergency Use Authorizations (EUAs) for special tests intended to detect the novel coronavirus. The Emergency Use Authorization is a special regulatory framework allowing to distribute and use medical devices before they are approved by the FDA, providing that such medical devices are vitally important for public health protection. Thus, the EUA framework is widely used to ensure and expand the availability of the most critical medical devices during the COVID-19 outbreak. This situation results in a significant increase of demand on transport media used to transport clinical specimens from the place they were collected from the patient to the accredited laboratory authorized to perform this type of testing, hence, the FDA takes all the measures necessary to ensure the uninterrupted availability of transport media devices since it impacts the availability of COVID-19 testing in general.
In particular, the scope of the FDA guidance on transport media covers medical devices used in the context of molecular or antigen testing:
- to stabilize and transport clinical specimens, usually obtained on swabs,
- with molecular or antigen assays for measuring various viral markers, and
- with molecular or antigen assays conducted on various test platforms.
The guidance also contains a table indicating the devices covered by the document, their product codes, classes under the risk-based classification, and also the numbers of applicable regulations.
Thus, the transport media devices falling within the scope of the guidance include:
- Viral transport media (VTM),
- Sterile phosphate-buffered saline (PBS), and
- Sterile normal saline.
The Agency also mentions that the document does not cover medical devices intended for viral inactivation, while VTMs are designed to sustain the viability of viruses instead.
US Regulations on Transport Media Devices
As it was already above, in this guidance the FDA describes the approach to be applied in order to ensure the availability and avoid shortages of transport media devices used in the context of COVID-19 outbreak with SARS-CoV-2 diagnostic tests.
In particular, the document describes the US regulation on transport media devices consisting of several policies.
The FDA also recommends ways to be used by medical device manufacturers to validate transport media designed to transport certain clinical specimens. However, medical device manufacturers may suggest other validation methods and discuss them with the Agency.
In particular, the medical device manufactures having their molecular or antigen tests allowed for marketing and use under the EUA framework should refer to the aforementioned document and also to the Conditions of Authorization section in the appropriate Letter of Authorization issued by the FDA to find additional information and recommendations regarding the way the changes to the labeling, instructions for use or to the transport media device itself should be made.
The Agency additionally emphasizes that in case if the laboratory will use any alternative components falling outside the scope of the initial authorization, such a modified device will not be deemed authorized. However, according to the aforementioned policy, the authority is not going to object to the use of EUA-authorized tests, including ones subject to modifications, providing that such modifications have been duly validated.
The second policy described by the FDA is addressed to the medical device manufacturers engaged in the manufacturing and distribution of transport media that are Class I medical devices under the US risk-based classification. This category covers transport media devices designed to be used for transporting clinical specimens for testing with molecular or antigen assays. Such transport media devices are also subject to 510(k) premarket notification requirements.
According to the FDA guidance on transport media devices, during the COVID-19 outbreak, the Agency does not intend to object to the distribution and use of vital transport media devices without submission of a 510(k) premarket notification to the regulating authority as required under the general rules, or demonstration of compliance with the Unique Device Identification (UDI) requirements, providing that such devices are duly validated. In order to benefit from such a simplification, the medical device manufacturer shall submit a notification of validation to the authority, while the device should be accompanied by the statement that it is not FDA-approved, and the appropriate indication in labeling. Under another simplification, the medical device manufacturer may also waive the Quality System Requirements, providing that compliance with the international standard ISO 13485:2016 is confirmed by the appropriate documents to be provided by the manufacturer.
Validation, Notification and Labelling Requirements for Transport Media Devices
As it was already mentioned before, any and all transport media devices should be properly validated before making them available to the laboratories and healthcare institutions. All such devices should be supplied sterile since it is necessary to ensure the accuracy of the test results. The general validation rules are set forth in the Centers for Disease Control and Prevention`s (CDC`s) Standard Operating Procedure (SOP): Preparation of Viral Transport Media. However, medical device manufactures may consider other validation methods.
Upon validation, the medical device manufacturer shall duly notify the regulating authority before commencing the distribution. In particular, the manufacturer shall provide its name, address, the details of the contact person and authorized representatives, and also the information about the medical device in question, including the trade name, instructions for use, and compliance documentation.
The labeling requirements for transport media devices are the same as applied for in vitro diagnostic medical devices.
Additionally, the information provided in labeling shall include:
- a statement indicating the intended purpose,
- Warnings and limitations,
- Shelf life indication,
- A list of materials,
- Specifications and performance criteria,
- Instructions for use covering such aspects as collecting specimens and transportation,
- Description of quality control procedures and materials required,
- Details about the manufacturer, including its name and place of business.
According to the guidance, it is also advised by the authority to include the following information:
- A statement indicating that the device has not been reviewed by the FDA under the general procedure,
- A culture media statement,
- Indications of compatibility,
- Additional instructions and technical details that could be useful for users,
- Contact information.
Summarizing the information provided here above, the FDA has implemented certain simplifications to reduce the regulatory burden related to the transport media devices in order to ensure and expand the availability of such devices during the pandemic since they are widely used and thus vitally important when performing COVID-19 tests.
It is important to mention that the present FDA guidance is subject to immediate implementation. The Agency intends to use such an approach instead of the public consultation procedure due to the current situation related to the public health emergency associated with the pandemic. At the same time, industry representatives are still allowed to submit their comments and suggestions to be taken into consideration by the Agency when preparing a new version of the policy. The document will remain effective only during the aforementioned public health emergency. Due to its legal nature, the document does not provide mandatory requirements to be followed by the parties involved in operations. The FDA guidance only provides non-binding recommendations instead, in order to assist with maintaining compliance with the applicable requirements.
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