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Not FDA approved devices. There is currently no universal standard for face/eye protection from biological hazards. Face shields are considered Class I medical devices that are exempt from Food and Drug Administration (FDA) Pre-Market Notification, but are subject to the FDA’s Quality System Regulation that includes periodic inspection. Face shields do not protect fully from impact hazards, so that OSHA requires their use in conjunction with additional eye protection (goggles, prescription spectacles with side shields, etc.).