FDA and CLIA Regulation

Companies with viable cheap paper tests face a regulatory catch-22 that prevents legal manufacture at scale. The FDA has no established regulatory pathway for a test whose primary purpose is population-level transmission reduction rather than individual diagnosis. The July 2020 FDA EUA template for over-the-counter COVID tests required 90% of PCR's molecular sensitivity, effectively disqualifying any truly cheap paper strip. Any test that produces a biological result likely to change an individual's behavior falls under CLIA jurisdiction, requiring laboratory certification or a formal CLIA waiver. Requiring electronic reporting of every negative result makes cheap paper strip tests logistically impractical for daily home use at population scale.