Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
Henley Ion LLC has released data showing its filter-less respirator device can remove more than 99% of SARS-CoV-2 bioaerosols. The mask prototype developed by physician and surgeon Julian Henley, uses micronized electrostatic precipitation (mEP) to remove infectious aerosol particles from both inhaled and exhaled air. Results from the study have been published in the Viruses journal and confirm the device can provide equivalent protection from infectious bioaerosols as N95 respirators.