FDA issues final guidance for devices labeled as sterile

Editor's Note

The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."

The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include in 510(k)s for devices labeled as sterile.

The guidance notes that the FDA recognizes there may be alterations to more recently developed sterilization methods, as well as original, innovative sterilization technologies, which are being developed and proposed for use with class I and II devices. The FDA considers these to be “novel” methods.