The U.S. Food and Drug Administration (FDA) today (March 30) issued a temporary guidance intended to expand the availability of surgical apparel for healthcare professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves, during the COVID-19 pandemic.
The guidance is being implemented without solicitation of prior public comments because the FDA has determined such action is not feasible or appropriate. “You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations,” the agency says in the guidance.
To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
Edited by Michael Causey