The Food and Drug Administration hereby informs all concerned stakeholders that FDA Advisory No. 2021-3604 entitled “Acceptance of Application for Special Certification for COVID-19 Self-Test Kits” is amended to change the date of start of receiving of applications for Special Certification for the said products from 16 January 2022 to 6 January 2022.
All other provisions of FDA Advisory No. 2021-3604 not affected by this Advisory shall remain valid and effective.
Dissemination of this Advisory to all concerned is hereby requested.