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[FDA NEWS] The FDA has revised the ultimate guidance on the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

Date: 1/22/2024

sterilization 510(k) submission

Introduction: In a recent development, the US Food and Drug Administration (FDA) has unveiled a comprehensive set of guidelines aimed at providing clarity on the information required for 510(k) submissions related to sterile devices. Titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," this guidance document serves as a valuable roadmap for both FDA professionals and industry insiders, offering key insights into the ever-changing realm of medical device sterilization.

Adaptation to Change: At the core of this guidance is the FDA's commitment to adapting to the evolving landscape of medical device sterilization. With the increasing adoption of nontraditional sterilization methods, the FDA seeks to establish clear guidelines for both established practices and novel approaches.

Key Highlights: The guidance document, as explained by its author, updates and clarifies information related to sterilization processes recommended for inclusion in 510(k)s for devices labeled as sterile. It also provides crucial details about pyrogenicity information that sponsors should incorporate into a 510(k) submission.

Distinguishing Traditional and Novel Methods: In response to a surge in 510(k) submissions incorporating nontraditional sterilization methods, the guidance draws a clear distinction between "Established" methods, encompassing traditional approaches like steam, dry heat, ethylene oxide, and radiation, and "Novel" methods, introducing innovative sterilization techniques.

Scope and Exclusions: The scope of the guidance is carefully defined, excluding specific cases such as sterilizers classified as medical devices, processes relying on microbial exclusion, those involving materials of animal origin, liquid chemical sterilants, and reprocessors of single-use devices. Additionally, it does not cover information on sterile reprocessing at healthcare facilities, which is addressed separately.

Guidance for Established Methods: For "Established" methods, the guidance emphasizes detailed descriptions, specifications, and the indication of 510(k) clearance. It underscores the necessity of stating the sterility assurance level (SAL) of 10-6 for devices labeled as sterile. While sterilization validation descriptions are required in the submission, actual validation data need not be included.

Guidance for Novel Methods: In the case of "Novel" methods, the guidance necessitates additional information alongside that required for "Established" methods. This includes a comprehensive description of the sterilization process, details on methods used to validate the sterilization cycle, and the inclusion of the validation protocol and data on sterilization validation.

Conclusion: This guidance document serves as a comprehensive blog-style roadmap for stakeholders in the medical device sterilization space. By offering clear information requirements, the FDA aims to streamline the 510(k) submission process, ensuring that both traditional and emerging sterilization methods adhere to stringent standards in this dynamic field. Stay tuned for more updates on the forefront of medical device innovation and regulation.

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