FDA Scolds Firms For Claims That Could Mislead The Public About COVID-19 Products
The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.
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US FDA investigators are chasing down scammers selling fraudulent COVID-19 treatments and tests. The agency said it is working with online retailers and domain name registrars to pull the products off websites, as well as trying to prevent them from entering the country.
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.