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US FDA Nukes HHS Decision To Exempt Medical Gloves, Other Products From Regulatory Oversight

The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.

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The US Food and Drug Administration rebuked the Department of Health and Human Services under secretary Alex Azar for publishing two notices earlier in the year that exempted medical gloves and other products from FDA oversight. The agency says it was not consulted on the decisions – despite the fact its name was attached to the notices.

On 15 January, the HHS and the FDA had published joint notices stating they would no longer require premarket notifications for seven low-risk medical devices, and may stop requiring them...

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