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Frequently Asked Questions

Can I develop my own virus transport media (VTM)?

FDA recommends that laboratories seeking to develop and use their own VTM refer to CDC's SOP: Preparation of Viral Transport Media.

Is transport media regulated by the transport media policy?

*** 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.

Can PBS/saline transport media be used by commercial manufacturers?

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.

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