> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CBER Sends Letter to Firm Over Unapproved HIV Tests
- URL: https://www.fdaweb.com/cber-sends-letter-to-firm-over-unapproved-hiv-tests/
- Published: 2017-05-24T12:00:00.000Z
- Updated: 2026-09-14T22:25:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138781

CBER Office of Compliance and Biologics Quality has cited the unnamed owner of a Web site ([*http://www.americanpumpkins.com*](http://www.americanpumpkins.com/?ref=fdaweb.com)) for promoting its In Home Blood Test for HIV 1 and 2 and the Oral In Home Saliva Test for HIV 1 and 2\. A just-posted [agency letter](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM560346.pdf?ref=fdaweb.com) says the devices are “not approved for sale in the United States and have not received investigational device exemptions from premarket approval... Moreover, the United States is included in the ‘drop-down’ box on the payment page, inviting orders for shipment of the products within the United States.”