"The researchers emphasize that this is not a project for typical do-it-yourselfers to undertake, since it requires specialized understanding of the clinical-technical interface, and the ability to work in consideration of strict U.S. Food and Drug Administration specifications and guidelines.
Such devices “have to be manufactured according to FDA requirements, and should only be utilized under the supervision of a clinician,” a team member said. “The Department of Health and Human Services released a notice stating that all medical interventions related to Covid-19 are no longer subject to liability, but that does not change our burden of care.” he said. “At present, we are awaiting FDA feedback” about the project. “Ultimately, our intent is to seek FDA approval. That process takes time, however.”"
Such devices “have to be manufactured according to FDA requirements, and should only be utilized under the supervision of a clinician,” a team member said. “The Department of Health and Human Services released a notice stating that all medical interventions related to Covid-19 are no longer subject to liability, but that does not change our burden of care.” he said. “At present, we are awaiting FDA feedback” about the project. “Ultimately, our intent is to seek FDA approval. That process takes time, however.”"