The FDA released guidance July 20 saying commercial viral transport media manufacturers can ship the products without having to file a premarket notification or comply with unique device identification requirements.
The agency said it is hoping to increase access to viral transport media.The exemptions will only be in place for as long as COVID-19 is considered a public health emergency.
Under the guidance, manufacturers are required to tell their viral transport media customers that the products haven’t gone through the standard regulatory review process.
Find the full guidance here.
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