FDA Fact Sheet - Fact Sheet for Patients The FDA “Fact Sheet for Patients – Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests” (updated Nov 15, 2021) explains, in plain language, what an EUA-authorized molecular LDT COVID-19 test is and why a patient may have been tested. It describes what positive and negative results mean, including the possibility of false results, and emphasizes follow-up with a healthcare provider for next steps. It also clarifies that the test is authorized under an EUA (not fully FDA approved/cleared) and points patients to CDC and FDA resources for current information. primary file regulatory fda-policy 2021-11-15_FDA Fact Sheet - Fact Sheet for Patients.md regulatory/fda-policy/2021-11-15_FDA Fact Sheet - Fact Sheet for Patients.md 2021_11_15 pdf Public Domain 960 1407 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url