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

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).

The 2008 version of this document did imply, but did not clearly specify, that endotoxin testing should be performed on implanted products. The draft guidance from 2008 stated:

The reviewer should document the testing performed to demonstrate that all blood contacting devices, permanent implants, devices that contact cerebrospinal fluid, and devices labeled pyrogen-free or non-pyrogenic are, in fact, non-pyrogenic.

The 2016 version is unmistakable regarding the expectations. It states:

Pyrogenicity testing is used to help protect patients from the risk of febrile reaction due