FDA Warns Against Fraudulent COVID-19 Tests and Treatments

In the past few weeks, the number of coronavirus (COVID-19) incidents has sky-rocketed in the U.S. with the epicenter seemingly in New York. Companies have been stepping up to the plate to get approvals and authorizations for tests and vaccines to combat the pandemic. This demand has also opened up the door for many companies to try and push fraudulent products onto the market with claims of treating or detecting COVID-19. FDA said it is cracking down on these fraudulent products. In a release, the agency said it has also “seen unauthorized fraudulent test kits for COVID-19 being sold online.” CNBC recently reported the Justice Department’s first enforcement action against COVID-19 fraud was a civil complaint against operators of the now defunct website coronavirusmedicalkit.com. CNBC reported the department of justice said the website operators offered consumers access to the World Health Organization’s vaccine kits in exchange for a shipping charge of $4.95 paid by credit card. In a release, FDA said “Currently, the only way to be tested for COVID-19 is to talk to your healthcare provider. FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” The agency also warns against claims of vaccines and products that can effectively treat the virus. In its release, FDA said “there are investigational COVID-1...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news