FDA Adds Denture Resin, Facet Screw Guidances To Safety And Performance Pathway
The documents lay out performance and safety criteria that the US agency expects the device types to meet to be cleared via the simplified track.
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Q&A: New Standard For Device Irritation Nudges Industry Away From Animal Testing – And Toward Tests On Lab-Made Human Skin
An ISO-recognized expert tells Medtech Insight why international standard ISO 10993-23:2021 urges irritation testing on laboratory-grown skin – also known as in vitro reconstructed human epidermis (RhE) – and why device makers will like it.
The US agency released three new guidance documents on 10 December detailing how certain devices can be cleared through a safety and performance pathway.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.