Edit: If you read this, please be sure to see the link for Dr. Bumpus at the end. I did save the best for last. Good manufacturing requirements were waived in the [December 12, 2022 amendment to EUA210661 for SD Biosensor Pilot COVID-19 At-Home Test.](https://www.fda.gov/media/155123/download) This probably has nothing to do with bacterial contamination of the test fluids, but we don't know that because FDA and the media are only giving us the contaminated lot numbers [without dates of manufacture.](#intensifies) Manufacture dates are commonly communicated with recall information, except for cases of FDA regulated medical products which could actually make you sick. [See the SD Biosensor Refunds page for details if you have purchased a recalled product.](https://www.sdbiosensor.com/refunds) ># III. Waiver of Certain Requirements I am waiving the following requirements for your product during the duration of this EUA: • **Current good manufacturing practice requirements**, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product, but excluding Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250). >... ## Signed by >[Namandjé N. Bumpus, Ph.D. Chief Scientist Food and Drug Administration](https://archive.ph/MKl6d)