FDA Cracks Down on Unauthorized Medical Device Modifications
The FDA has recently issued a Warning Letter to a medical device manufacturer for making unauthorized modifications to a previously cleared device under the 510(k) pathway. In a nod to…
Dexcom cited for cGMP violations
Regulatory News | 25 March 2025 | Ferdous Al-Faruque Dexcom headquarters in San Diego, CA. (Source: iStock) The US Food and Drug Administration (FDA) has cited Dexcom, a continuous glucose meter (CGM) manufacturer, for…