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).
New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants
Published In: Orthopedic Technology & Design
November 22, 2016
BS, RM/SM (NRCM), CISS-RAD
Scientific Competency Expert
Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.