FDA Response Letter - To Complaint regarding FDA Reference Panel from Dec 2020 FDA's September 2023 formal response to a December 2020 Information Quality Act complaint filed by Hyman, Phelps & McNamara on behalf of EUA test developers who alleged that the FDA SARS-CoV-2 Reference Panel Comparative Data was inaccurate and misleading. FDA denies the complaint, defending the reference panel and protocol as scientifically sound for comparing relative limits of detection, noting that participation and public posting were EUA conditions of authorization, and explaining that the data had already been removed as outdated—not due to accuracy concerns. primary file regulatory fda-policy 2023-09-23_FDA Response Letter - To Complaint regarding FDA Reference Panel from Dec 2020.md regulatory/fda-policy/2023-09-23_FDA Response Letter - To Complaint regarding FDA Reference Panel from Dec 2020.md 2023_09_29 pdf Public Domain 3013 4110 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