Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff
This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that we recommend sponsors include in a 510(k) submission. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database Web site here.
Published on the 8th of January 2024. Read the entire news report on the FDA’s website following this link.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (7 août 2024). Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/1258v





