The US Food and Drug Administration (FDA) has issued guidance to help expand the availability of surgical apparel for health care professionals, including gowns, hoods and gloves.
The policy is intended to remain in effect only for the duration of the public health emergency related to Covid-19 declared by the Department of Health and Human Services (HHS), the FDA said yesterday (30 March).
Given the public health emergency, the FDA noted the guidance has been implemented with immediate effect.
“FDA is taking steps to help expand the availability of gowns and other apparel and believes the policy set forth in this guidance may help address the urgent public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies that FDA intends to apply to gowns and other apparel, including these products’ associated indications and claims,” it said.
Click here to access the guidance.
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