What is vtm test for covid?

This page provides answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.

This page includes questions and answers regarding the policies outlined in the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

On this page, this guidance is referred to as the COVID-19 Transport Media Policy.

For information regarding the development and performance of tests for SARS-CoV-2, please see the FAQs on Testing for SARS-CoV-2 webpage.

A: This table shows product codes for different types of transport medium products.

* Generally, transport media consisting of PBS/saline would be regulated by this regulation. ** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390. *** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation.

Please note that products in product code QBD are not within the scope of the COVID-19 Transport Media Policy. The remainder of the product codes listed above are within the policy's scope.

A: As explained in the COVID-19 Transport Media Policy, only VTM devices labeled as sterile should be used in the transport of clinical specimens to avoid introducing microbial contamination in to the specimen. FDA's guidance further explains that the sterility of transport media should be appropriately verified and/or validated prior to distribution, and this should include process sterilization validation and validation that the device remains sterile in its packaging when maintained in accordance with the labeled storage conditions and for the duration of the claimed shelf life.

A: No, the policies outlined in the COVID-19 Transport Media Policy only apply to certain transport media devices that can be used to transport certain clinical specimens that are tested by molecular or antigen diagnostic assays for use during availability concerns resulting from the COVID-19 public health emergency. This includes sterile VTM that have been designed and validated consistent with the current version of the CDC's SOP for the Preparation of Viral Transport Media as well as sterile phosphate buffered saline (PBS)/saline transport media.

As discussed in the guidance, these policies are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

This table shows product codes for the different types of transport medium products that are referenced in the policies in the COVID-19 Transport Media Policy.

* Generally, transport media consisting of PBS/saline would be regulated by this regulation. ** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390.

A: Yes, section IV.B of the COVID-19 Transport Media Policy discusses policies specific to commercial manufacturers of certain types of viral transport media that are class I (reserved) and subject to premarket notification requirements under section 510(k) of the FD&C Act. As discussed in the guidance, FDA does not intend to object to the distribution and use of VTM by commercial manufacturers, without a 510(k) and without compliance with the Unique Device Identification (UDI) requirements, where the VTM device is validated, notification of validation is provided to FDA, and certain labeling information is included with the VTM device.

A: As stated in the guidance, FDA believes that VTM distributed by commercial manufacturers under this policy should be designed and validated consistent with the Centers for Disease Control and Prevention's (CDC's) Standard Operating Procedure (SOP): Preparation of Viral Transport Media. Generally, transport media may contain different components to serve the function of stabilizing viruses, and FDA understands that some commercial manufacturers may wish to design and validate VTM formulations that may differ from the CDC's SOP for the Preparation of Viral Transport Media. As discussed in section IV.B.4 of the COVID-19 Transport Media Policy, FDA is interested in interacting with commercial manufacturers of alternative formulations of viral transport media that may wish to discuss alternative approaches to validation that are not identified in the policy. Commercial manufacturers that wish to discuss an alternative formulation or validation approach should email CDRH-EUA-Templates@fda.hhs.gov.

A: No. The policies outlined in the COVID-19 Transport Media Policy only apply to transport media that are intended to sustain the viability of viruses/other organisms and therefore, do not contain substances such as guanidinium/guanidine or similar chemicals intended to inactivate viruses. The policies in this guidance do not apply to transport media devices intended for viral inactivation, commonly referred to as inactivating transport media (ITM).

A: Yes, section IV.C of the COVID-19 Transport Media Policy outlines policies for commercial manufacturers of sterile saline and PBS transport media. These devices are generally exempt from premarket notification requirements under section 510(k) of the FD&C Act pursuant to 21 CFR 866.2300(b) (Class I Exempt). As discussed in the guidance, FDA does not intend to object to the distribution and use of PBS/saline transport media by commercial manufacturers, without compliance with the Unique Device Identification (UDI) requirements, when the manufacturer gives notification of validation to FDA.

A: Yes, transport media are required to comply with all requirements, including 21 CFR Part 820; however, as discussed in the COVID-19 Transport Media Policy, in order to help increase availability of commercially manufactured transport media, FDA does not intend to enforce the Quality System Requirements under 21 CFR Part 820 when commercial manufacturers of VTM or sterile PBS/saline transport media within the scope of the guidance conform to ISO 13485:2016 Medical Devices ̶ Quality Management Systems ̶ Requirements for Regulatory Purposes. The guidance further explains that manufacturers should have documentation demonstrating their compliance with ISO 13485 which should be sent to FDA as part of the manufacturer's notification.

A: As discussed in the COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) devices or PBS/saline transport media devices where the manufacturer gives notification of validation of their transport media devices as outlined in the policy.

The COVID-19 Transport Media Policy explains that following completion of validation, notification that the commercial manufacturer intends to distribute the transport media should be provided to FDA by e-mail to CDRH-EUA-Templates@fda.hhs.gov that the transport medium has been validated. This notification should include the name of the manufacturer, address, a contact person and e-mail address at which the contact person can be reached, the name(s) under which the product is sold or distributed, names of authorized importers and distributors, a copy of the instructions for use, and a statement and documentation that the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Commercial manufacturers of VTM should also include a statement that the device has been designed and validated consistent with CDC's SOP: Preparation of Viral Transport Media. The FDA will acknowledge receipt of this email via auto-reply.

Additionally, FDA notes in the COVID-19 Transport Media Policy that it would be helpful to the FDA if manufacturers additionally provide information on their expected manufacturing capacity of their transport medium in their notification discussed above. This information will help the Agency and Department monitor the landscape as we work to help ensure adequate testing supplies are available across the country during the COVID-19 public health emergency.

As discussed in section IV.D of the COVID-19 Transport Media Policy, FDA does not expect laboratories to notify FDA if they plan to develop and use a transport media within the same corporate organization and common ownership by the same parent corporation.

A: As discussed in sections IV.B and IV.C of the COVID-19 Transport Media Policy, FDA does not intend to object to the distribution and use of the applicable products without compliance with certain requirements outlined in the policy. This policy does not apply to compliance with other requirements and manufacturers are responsible for ensuring compliance with those requirements, including Registration and Listing requirements in 21 CFR Part 807, reports of corrections and removals in 21 CFR Part 806, medical device reporting under 21 CFR Part 803, and in vitro diagnostics (IVD) labeling requirements under 21 CFR Parts 801 and 809.

A: Yes, section IV.D of the COVID-19 Transport Media Policy outlines policies applicable to laboratories certified under CLIA that meet the requirements to perform high-complexity testing. As discussed in the guidance, FDA does not intend to object to the development and use of transport media, including VTM, or PBS/saline, for transport of clinical specimens by laboratories certified under CLIA to perform high-complexity testing that meet the requirements to perform high-complexity testing where the transport medium has been validated in-house and where use of the transport medium is limited to laboratories within the same corporate organization and having common ownership by the same parent corporation. FDA does not expect laboratories to notify FDA if they plan to develop and use a transport media within the same corporate organization and common ownership by the same parent corporation.

The COVID-19 Transport Media Policy further recommends that all transport media should be validated prior to use. FDA recommends that laboratories seeking to develop and use their own VTM refer to CDC's SOP: Preparation of Viral Transport Media.

Laboratories seeking to distribute transport media to entities that are not within the same corporate organization and that share common ownership by the same parent corporation should refer to section IV.B or section IV.C of the COVID-19 Transport Media Policy.

A: As described in section IV.B of the FDA's COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) by commercial manufacturers, without a 510(k) or compliance with the Unique Device Identification (UDI) requirements, where the VTM device is validated, notification of validation is provided to FDA, and certain labeling information is included with the VTM device.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute VTM as set forth in Section IV.B of the FDA's COVID-19 Transport Media Policy.