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Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid

 
• By Brian Bossetta

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

• Source: Shutterstock

Since 2012, class I recalls have increased with medical devices leading the way, according to Anne Reid, program director of the FDA’s Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), who discussed the trend during the 2024 MedCon conference on 24 April.

Class I recalls, Reid said, consume the resources of the agency as well as industry.

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