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New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants

By: Martell Winters, Senior Scientist and Consulting Manager; Quinton Inglet, Section Leader, Bacterial Endotoxin Testing
Published: Orthopedic Technology & Design

The document could have a significant impact on the testing regimen for implant device manufacturers. The U.S. Food and Drug Administration (FDA) released a new guidance document titled “Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile” on Jan. 21, 2016, which underwent some small editorial changes and was updated in March. This document has resulted in far-reaching changes to the 510(k) submission process for implant manufacturers. Of note, it specified new requirements related to bacterial endotoxin testing (BET).

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