Misbranded Product and COVID-19
On May 7th 2020, FDA issued a news release about the "Fraudulent COVID-19 Medical Products" and indicated that 42 warning letters was issued to companies making bogus COVID-19 claims. In addition, the agency has discovered hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims. By working with online marketplaces, domain name registrars, payment processors and social media websites, the agency spent quite a lot of resources to identify the fraudulent products and ask to remove from their platforms products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19. You can in fact report a potentially unlawful sales of medical product on the internet here and the FDA will evaluate your compliant and take suitable action. The FDA also put out resources that helps public understand the regulatory information you might need to identify potential fraudulent product.
HyperClear is committed to establish traceability on medical products and in turns prevent fraudulent medical products to be distributed to the public. All vendors who signs up on HyperClear will be screened against criteria such as establishment registration and product listing at the FDA database. It would not be possible to sell unauthorized products with false or misleading claims on HyperClear because the unique blockchain network of HyperClear that allows stakeholders (e.g. manufacturers, distributors, hospital systems, retailors) to access the product information queried from authorized database such as GUDID or from product UDI. HyperClear look forward to helping stakeholders out there to establish product traceability via our platform for any potential post-market actions (e.g. compliant, recall..etc) and consolidate traceability information in one place.