510(k) Submissions for Devices Labeled as Sterile: How to Approach the Inclusion of Sterility Information

Mar 12, 2024 | White Paper |

REG-2401 Teaser Pic

The landscape surrounding Medical Device Sterilization has evolved as FDA looks to dedicate resources, develop programs, and foster innovation in the field. To reflect these changes, FDA released the updated final guidance document “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” on January 8, 2024.  

This MEDIcept Whitepaper dives into the background and current landscape of sterilization for medical devices, breaks down FDA’s new guidance document and gives manufacturers a better understanding of submitting sterility information in a 510(k) for medical devices labeled as sterile.  

Click to read the MEDIcept White Paper!