FAQs on Testing for SARS-CoV-2 | FDA

FAQs on Testing for SARS-CoV-2 | FDA

October 7 Update: New Information on Testing for SARS-CoV-2

Thank you for your interest in the development of diagnostics for SARS-CoV-2. 

The FDA recently:

UPDATED the answer to the following questions:

• Which alternative specimen types and swab types can I use for COVID-19 diagnostic testing?
• What are the regulatory requirements for 3D printed swabs, whether fabricated by a commercial manufacturer or at a hospital, laboratory, or other facility?
• How should I evaluate my 3D printed swab?

ADDED the following questions and answers:

• Is there an example of anterior nares swabbing instructions that I could provide to my patients?
• What are FDA's priorities with respect to review of EUA requests for COVID-19 tests?

See Update to FAQs

Questions?

Email CDRH-EUA-Templates@fda.hhs.gov