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FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body

Guidance Seeks To Clarify Use On International Standards

 
• By Brian Bossetta

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.

BIOCOMPATIBLE
• Source: Shutterstock

The US Food and Drug Administration published a final guidance document 8 September to aid industry in preparing premarket applications (PMAs), humanitarian device exceptions (HDEs), investigational device applications (IDEs), premarket notifications (510(k)s), and de novo requests.

The guidance seeks to help sponsors submitting these applications to determine the potential for an adverse biological response that may occur when various materials from the subject device contact the...

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