FAQs on Viral Transport Media During COVID-19
November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end . Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
This page provides answers to frequently asked questions relating to COVID-19 enforcement policy guidances that are no longer in effect for transport media devices. These policies were discussed in Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, which is no longer in effect, and is referred to on this page as the COVID-19 Transport Media Policy.
As the COVID-19 Transport Media Policy is no longer in effect, this page no longer includes a list of commercial manufacturers developing and distributing viral transport media (VTM) under the policy outlined in Section IV.B of the COVID-19 Transport Media Policy. For a list of all VTM devices that have been 510(k) cleared, see devices with product code JSM in the FDA's medical devices database for 510(k):
On this page:
- Which product codes are used for transport medium products?
- Is FDA continuing the enforcement policy described in the COVID-19 Transport Media Policy applicable to viral transport media (VTM) now that that guidance is no longer in effect?
- Is FDA continuing the enforcement policy described in the COVID-19 Transport Media Policy applicable to PBS/Saline transport media devices now that that guidance is no longer in effect?
- How do commercial manufacturers of viral transport media prepare for traditional marketing authorization and submissions?
- Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820?
- Do I need to register my establishment with the FDA and list my device if I am developing and distributing transport media? Do I need to comply with any other FDA requirements?
Q: Which product codes are used for transport medium products?
A: This table shows product codes for different types of transport medium products.
| Classification Regulation | Device Type | Product Code | Device Classification |
|---|---|---|---|
| 21 CFR 866.2300* | Culture Media, Non-Selective and Non-Differential | JSG | I (Exempt) |
| 21 CFR 866.2390** | Culture Media, Non-Propagating Transport | JSM | I (Reserved) |
| Culture Media, Anaerobic Transport | JSL | I (Reserved) | |
| Culture Media, Propagating Transport | JSN | I (Reserved) | |
| 21 CFR 866.2900** | Device, Specimen Collection | LIO | I (Reserved) |
| System, Transport, Aerobic | JTW | I (Reserved) | |
| Transport Systems, Anaerobic | JTX | I (Reserved) | |
| 21 CFR 866.2950*** | Microbial Nucleic Acid Storage and Stabilization Device | QBD | II |
* 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.
Q: Is FDA continuing the enforcement policy described in the COVID-19 Transport Media Policy applicable to viral transport media (VTM) now that that guidance is no longer in effect?
A: FDA is not continuing the enforcement policy described in the COVID-19 Transport Media Policy now that that guidance is no longer in effect, including with respect to VTM.
However, as outlined in the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance, FDA does not intend to object to continued distribution of devices within the scope of the guidance where a required marketing submission has been submitted and accepted by the FDA by November 7, 2023, and where FDA has not taken a final action on the marketing submission. The policy described in the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance does not apply after FDA has taken a final action on the marketing submission.
FDA expects manufacturers to discontinue distribution of a device within the scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance on the date the manufacturer receives a negative decision on its marketing submission as FDA's final action, among other circumstances. In addition, manufacturers should be aware of any applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part 803, and continue to comply with such requirements for the duration in which they are applicable, which may extend beyond the cessation of distribution.
For more information about the FDA's acceptance policies for marketing submissions, see the following FDA guidance documents:
- Refuse to Accept Policy for 510(k)s
- Acceptance Review for De Novo Classification Requests
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Q: Is FDA continuing the enforcement policy described in the COVID-19 Transport Media Policy applicable to PBS/Saline transport media devices now that that guidance is no longer in effect?
A. FDA is not continuing the enforcement policy described in the COVID-19 Transport Media Policy now that that guidance is no longer in effect, including with respect to PBS/saline transport devices.
PBS/saline transport media are generally exempt from premarket notification requirements under section 510(k) of the FD&C Act; however, manufacturers of such devices must comply with other applicable 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.
Q: How do commercial manufacturers of viral transport media prepare for traditional marketing authorization and submissions?
A: If commercial manufacturers have questions about their transition plans for their VTM devices or questions about a future 510(k) or other traditional marketing submission, the FDA encourages them to contact us one of these ways:
- Send an email to the EUA templates mailbox with sufficient details so the FDA can provide appropriate feedback, or
- Submit a Pre-Submission (also known as a Q-Submission) for your VTM device. Please review the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program for additional information about this program.
Q: Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820?
A: Yes, transport media are required to comply with the quality system regulation, 21 CFR Part 820, as applicable. The policies previously included in the COVID-19 Transport Media Policy are no longer in effect.
Q: Do I need to register my establishment with the FDA and list my device if I am developing and distributing transport media? Do I need to comply with any other FDA requirements?
A: Yes, manufacturers of transport media are responsible for ensuring compliance with applicable legal 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.