METADATA last updated: 2026-03-05 by BA file_name: 2021-04-02_FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254.md file_date: 2021-04-02 title: FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254 category: regulatory subcategory: fl-fda-correspondence tags: source_file_type: gdoc xfile_type: docx gfile_url: https://docs.google.com/document/d/1qbX9jeURHdrgrreOVksMThNkB1mP77W3oO28vz0WSSA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/fl-fda-correspondence/2021-04-02_FloodLAMP%20FDA%20Correspondence%20-%20Deprioritization%20EUA210252%20EUA210254.docx pdf_gdrive_url: https://drive.google.com/file/d/1XOKe8WQZNDY0Bfl8VbKakCQ719mq-TtC pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/fl-fda-correspondence/2021-04-02_FloodLAMP%20FDA%20Correspondence%20-%20Deprioritization%20EUA210252%20EUA210254.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 1309 words: 675 notes: summary_short: The April 2, 2021 FDA email and attached deprioritization letter notify FloodLAMP that EUA210252 (QuickColor COVID-19 Test) was closed because FDA declined to review it under then-current prioritization criteria. It explains that, in a later phase of the pandemic with many tests already authorized, FDA prioritized requests expected to materially increase U.S. testing accessibility (e.g., POC, home collection, at-home) or capacity (e.g., high-throughput), and judged FloodLAMP’s submission as having relatively limited impact on those factors. The document also notes the same decision and attachment were issued for a related EUA request (EUA210254). CONTENT ***INTERNAL TITLE:*** 2021-04-02_Email from FDA - Final Decision and Deprioritization ## Email Header from: Walia, Vijay <Vijay.Walia@fda.hhs.gov> to: "randy@floodlamp.bio" <randy@floodlamp.bio> cc: "Caposino, Paula" <Paula.Caposino@fda.hhs.gov>, "St. Pierre, Don J." <don.st.pierre@fda.hhs.gov>, "Roth, Kristian" <Kristian.Roth@fda.hhs.gov>, oir-policy <CDRH-OIR-POPS@fda.hhs.gov>, "EUA210252@docs.fda.gov" <EUA210252@docs.fda.gov> date: Apr 2, 2021, 1:18 PM subject: Final Decision for EUA210252 Request – letter attached ## Email Body Dear Randall J. True, Please see attached letter regarding your EUA request, EUA210252. This is the final decision on your EUA request, and your EUA is now closed. The reason for our decision is that we are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized. We prioritize review of EUA requests for tests taking into account a variety of factors, as discussed in the [Emergency Use Authorization of Medical Products and Related Authorities Guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities), such as the public health need for the product and the availability of the product. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., high-throughput tests). Regarding your request, FDA determined that review of your EUA request is not a priority because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity in the United States. For additional information on FDA's priorities with respect to review of EUA requests for COVID-19 tests, see our website’s [FAQs on Testing for SARS-CoV-2](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#5f9fefc60116f). Please confirm receipt of this email and attached letter. Thank you, Best Regards, Vijay **Vijay Walia PhD MBA** *Scientific Reviewer* **Division of Chemistry and Toxicology Devices \| OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality** **CDRH \| U.S. FDA ** White Oak, Bldg 66 10903 New Hampshire Ave., Silver Spring, MD 20993 Vijay.Walia@fda.hhs.gov P: (301) 796-6139 ## ATTACHMENT: EUA210252.IVD Deprioritization Letter_Decline to Review - FINAL (DJS).pdf (text from attached pdf copied below - Same Email and Attachment for EUA210254) April 2, 2021 Randall J. True o/b/o FloodLAMP Biotechnologies, a DE Public Benefit Corporation 4860 Alpine Rd. Portola Valley, CA 94028 Re: EUA210252 Dear Randall J. True: This letter is in response to your request for an Emergency Use Authorization (EUA) for the FloodLAMP QuickColor COVID-19 Test, intended for the following use(s): for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested at a weekly interval with no more than 9 days between tests. Given the volume of EUA requests the Agency has received, FDA is prioritizing review of EUA requests for tests, taking into account a variety of factors such as the public health need for the product and the availability of the product.(1) Based on your request, FDA has determined that review of your EUA request is not a priority(2) because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity. FDA therefore declines to review the EUA request for the product at this time. This test has not been authorized to be distributed or used as proposed. FDA is committed to doing everything possible to help combat the COVID-19 outbreak and appreciates your efforts in this matter. Sincerely, Donald J. St.Pierre Deputy Director, New Product Evaluation OHT7:Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Food and Drug Administration (1) For example, the agency has prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, high-throughput, widely distributed tests). See [https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2#priorities](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2#priorities). (2) FDA’s current thinking on prioritization of EUA requests is explained in FDA’s guidance, “Emergency Use Authorization for Medical Products and Related Authorities,” available at [https://www.fda.gov/media/97321/download](https://www.fda.gov/media/97321/download).