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FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration

The US HHS and the FDA on 14 January published a notice that permanently waives premarket notification requirements for seven types of gloves that were given temporary waiver during the pandemic. Regulators are looking to expand the waiver to 84 other products.

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The US Food and Drug Administration will no longer require premarket notifications for seven low-risk medical devices, and may stop requiring them for 83 more moderate-risk devices and an unclassified device.

The agency issued emergency guidance documents during the COVID-19 pandemic that temporarily suspended premarket notifications for a slew of class I low-risk products including clinical electronic thermometers, and personal protective...

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