New FDA Site Walks Sponsors Step-By-Step Through Biocompatibility Requirements
Executive Summary
The agency has developed a user-friendly four-step process sponsors can use to address biocompatibility issues based on its 2016 biocompatibility guidance.
You may also be interested in...
NuVasive Recalls Orthopedics Implants Over Biocompatibility Concerns
The US FDA says the company has voluntarily issued a recall for Precice metal implants after reports of adverse events that could be related to the design of the product or biocompatibility issues.
FDA Proposes Negating Need For Biocompatibility Testing For Certain Materials
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.
Final Q-Sub Guidance Describes FDA Meeting Policy
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.