New FDA Site Walks Sponsors Step-By-Step Through Biocompatibility Requirements
The agency has developed a user-friendly four-step process sponsors can use to address biocompatibility issues based on its 2016 biocompatibility guidance.
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The agency says sponsors of some medical devices that touch skin may no longer need to provide biocompatibility testing data if the materials they’re made of have a safe history.
A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.