FDA Approves New Type of Treatment for Hairy Cell Leukemia

The treatment is not recommended for patients with severe renal impairment. Read More

International Devices and Diagnostics Monitor

Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More

FDA Approves Device for Treatment of Acute Coronary Artery Perforations

The agency granted the approval through the humanitarian device exemption pathway. Read More

483sOnline.com Your Personal Pre-inspection Toolkit

Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
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