FDA issues enforcement policy for coronavirus transport media

Regulatory NewsRegulatory News | 20 July 2020 |  By 

The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.
The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW and JTX.
FDA says the policy applies to viral transport media (VTM), sterile phosphate buffered saline (PBS) and sterile normal saline but does not apply to devices under product code QBD that contain substances intended to inactivate a virus.
Within the guidance, FDA lays out specific policies for commercial manufacturers of VTM and PBS/saline transport media devices and transport media developed and used by Clinical Laboratory Improvement Amendments (CLIA) certified high-complexity labs.
During the COVID-19 public health emergency, FDA says it does not intend to object to the distribution and use of VTM by commercial manufacturers without a 510(k) submission or compliance with unique device identification (UDI) requirements, so long as the product does not create an undue risk and follows the validation and notification requirements listed in the guidance. FDA also says it will not enforce quality system requirements for manufacturers that conform to ISO 13485:2016.
Manufacturers of VTM will still need to follow other requirements for registration and listing, reports of corrections and removals, medical device reporting and in vitro diagnostics labeling.
Similarly, for PBS/saline transport media devices, which are exempt from 510(k) requirements, FDA says it does not intend to enforce UDI requirements or quality system requirements for companies that conform to ISO 13485:2016.
“To reduce the risk of inaccurate test results, only PBS/saline devices labeled as sterile should be used in the transport of clinical specimens. Sterile PBS/saline devices 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,” FDA writes.
For both VTM and PBS/saline transport media, FDA says manufacturers should notify it by email that they have validated, and intend to distribute, transport media devices under the policies laid out in the guidance. FDA says it intends to maintain a list of transport media manufactured and distributed under the policies on its website.
Additionally, FDA says it does not intend to object to the development and use of VTM or PBS/saline transport media by CLIA-certified high complexity labs when the devices have been validated in-house and will only be used by laboratories within the same corporate organization without first notifying the agency.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy