Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported to and sold in the US, the agency says. The alert also tells consumers how to spot counterfeit tests.
The US Food and Drug Administration is warning customers and distributors to watch for counterfeit at-home COVID-19 tests, which have not been assessed by the agency and may carry a risk of false results. At least two types of counterfeit tests are being sold in the US.
“You may risk unknowingly spreading COVID-19, and may delay or stop appropriate medical treatment for COVID-19 if you use a counterfeit test,” the FDA explained.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
