Complaint Letter to FDA regarding Reference Panel - IQA-Request-Hyman-Phelps-McNamara A December 2020 Information Quality Act complaint filed by law firm Hyman, Phelps & McNamara on behalf of unnamed EUA test developer clients, challenging the accuracy of the FDA SARS-CoV-2 Reference Panel Comparative Data published on the FDA website. The letter argues that flaws in the reference panel protocol—particularly variable performance of heat-inactivated virus in negative clinical matrix—produced unreliable limit-of-detection results, and requests that FDA remove the data, issue a corrective public statement, and make the panel's validation data publicly available. primary file regulatory fda-policy 2020-12-22_Complaint Letter to FDA regarding Reference Panel - IQA-Request-Hyman-Phelps-McNamara.md regulatory/fda-policy/2020-12-22_Complaint Letter to FDA regarding Reference Panel - IQA-Request-Hyman-Phelps-McNamara.md 2020_12_22 converted using prompt file - not checked pdf Public Domain 1984 2717 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