Four members of the U.S. House Energy and Commerce Committee said in a July 22 letter to the Federal Trade Commission that scammers have capitalized on consumer fear regarding the COVID-19 pandemic by offering sham treatments, vaccines and diagnostics, highlighting in particular tests for antibodies for the SARS-CoV-2 virus. The letter makes note of an FBI advisory that the objective of these scams is to obtain sensitive personal information, such as Social Security numbers and dates of birth, and that the scam may include provision of false positive test results. The letter requests that the FTC report back to the committee by Aug. 5 with information regarding the extent to which such scams are being perpetrated and what resources the agency is deploying to counter such operations.
The European Commission has launched a new series of web pages to provide industry with updates on new developments in device regulation, replacing a similar set of Internet locations elsewhere on the agency’s web site. The agency also posted a list of essential medical devices for the COVID-19 pandemic, which also provides regulatory descriptions and product codes. EMA added a new guidance regarding conformity assessments for personal protective equipment, along with a timeline for implementation of the overhaul of regulations for medical devices and in vitro diagnostics. The agency’s latest survey of notified bodies includes information such as the typical elapsed time for NB review of COVID-related devices.