FDA is exempting suppliers of viral transport media from certain regulatory requirements to help ensure availability of materials needed to test for the coronavirus.
In a guidance published Monday, the agency said it will allow commercial media manufacturers to ship products without filing a 510(k) premarket notification or complying with unique device identification (UDI) requirements.
Coupled with similar exemptions for laboratories and manufacturers of saline transport media, FDA believes the action can help expand U.S. access to the materials needed to transport specimens for molecular RT-PCR or antigen-based testing for COVID-19.
The rapid, worldwide scaling up of testing for SARS-CoV-2 has placed strains on the diagnostic supply chain, leading to shortages of key materials even when diagnostic tests themselves are available.
FDA has now moved to lessen that testing bottleneck with guidance that could increase access to viral transport media. The guidance features three policies designed to clear barriers to the market faced by different groups of media suppliers.
The agency dedicates most of the document to commercial suppliers. Typically, such companies need to file a premarket notification and comply with UDI and quality system rules. FDA is dropping those requirements throughout the COVID-19 emergency, provided companies validate media, conform with an ISO quality system standard, and tell customers they have not undergone regulatory review.
The guidance describes how companies can validate media, pointing to a Centers for Disease Control and Prevention document as a reference, and explains the process for notifying FDA of the shipment of products that have not undergone regulatory review. The agency wants manufacturers to include details of their expected manufacturing capacity with their notifications.
Other sections of the guidance address FDA’s approach to commercial manufacturers of saline media and CLIA-certified laboratories. FDA is exempting saline media manufacturers from UDI and quality system requirements. Such manufacturers are generally already exempt from 510(k) requirements. The agency is also clearing CLIA-certified labs to develop transport media for internal use.
The exemptions come with similar caveats to the relaxed rules on commercial manufacturers of viral transport media. For example, FDA wants manufacturers of saline transport media to validate that their products remain sterile in packaging and notify it of the findings of their verification studies.