Eurofins NTD will track adverse events related to SARS-CoV-2 testing and report to the FDA as stipulated under 21 CFR Part 803. The laboratory will maintain all information on the performance of SARS-CoV-2 tests and report to the FDA any suspected changes in performance as soon as the laboratory becomes aware of them. The laboratory will maintain all records associated with any Emergency Use Authorization (EUA) related to SARS-CoV-2 testing and ensure these records are maintained until notified otherwise by the FDA. Such records will be made available to the FDA for inspection upon request.
For healthcare providers or patients that wish to report directly to the FDA any adverse event related to SARS-CoV-2 testing, including problems with test performance or results, they may submit FDA Form 3500 through the FDA’s online reporting portal, MedWatch. Alternatively, healthcare providers or patients may report an adverse event by calling 1-800-FDA-1088.