OraWellUSA in Philadelphia has stopped manufacturing its HIV test kits following inspections by the U.S. Food and Drug Administration earlier this year, according to a warning letter from the FDA.
The OraWellUSA™ HIV 1/2 Antibody Saliva Rapid Screen Test kits, which are classified by the FDA as class III medical devices, had not received an investigational device exemption from premarket approval, the letter said. Additionally, the company had failed to inform the FDA of its intention to launch the testing kits into commercial distribution.
A lawyer for the Philadelphia-based company led by Gerald R. Austin, sent a letter dated Aug. 31 that indicates the business had halted production of the testing kits, the warning letter noted.
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Although the HIV testing kits were sold on Amazon.com, according to a press release published in June, it is no longer available on the online shopping channel. According to the company’s Facebook page, it is available in Europe and Africa.
Class III medical devices must receive premarket approval or an investigational device exemption, according to the letter.
