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.
FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body
Guidance Seeks To Clarify Use On International Standards
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.
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