Business · 21/01/2016Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Sterility Information in 510(k) Submissions for Sterile Devices
The FDA has updated its guidance on sterilization processes and pyrogenicity information for devices labeled as sterile, providing clarity for industry sponsors and FDA staff.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →