FDA Sends Warning Letter To Integra Following Recall Of Surgical Repair Products
Executive Summary
After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.
You may also be interested in...
FDA Updates Breakthrough Devices Guidance To Improve Health Equity
The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.
Class I Recall For Abbott Implantable Pulse Generators
Abbott Medical has recalled several models of its implantable pulse generators (IPGs). The devices are part of the company’s Proclaim neurostimulation systems, which deliver low-intensity electrical impulses to nerve structures.
FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body
The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.