The U.S. FDA said in an updated FAQ for ventilators for the COVID-19 pandemic that open-source ventilator designs may be helpful in efforts to increase production, but that the use of such designs does not relieve a manufacturer of its regulatory liabilities. Any ventilator thus designed would be subject to premarket review requirements and “may be eligible” for addition to the ventilator EAU list. The same conditions and stipulations hold for 3D printing software used to manufacture ventilators.

The U.S. Securities and Exchange Commission has temporarily suspended the trading of securities for three companies due to questions regarding public communication made regarding products associated with the COVID-19 pandemic. Among the companies is Predictive Technology Group Inc., of Salt Lake City, for statements made in connection with distribution of serology tests for the SARS-CoV-2 virus. Trading was also halted for Spectrum DNA Inc., of Spokane, Wash., in connection with saliva collection devices, and SC Worx Corp., of New York, for unspecified tests for the virus. The shares of these companies will not be available for trade between April 22 and May 5, 2020.

No Comments