Joe Thomas

Joe Thomas

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Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device...

​​​​​​​When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more

11/22/2022  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Misbranding , Pre-Market Notification , Premarket Approval Applications , Warning Letters
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