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USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and Radiological Health released the final guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".


In this guideline, the scope of review is limited to 510(k)s for devices labeled as sterile, which undergo industrial terminal sterilization processes based on microbial inactivation. Examples of these processes include radiation, steam, EO, and new technology sterilization processes.


This guidance updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile, also discusses what information sponsors should include when submitting a 510(k) concerning pyrogenicity.


FDA considers there to be two categories of sterilization methods currently used to sterilize medical devices in manufacturing settings:

A. Established Sterilization Methods

  • Established Category A: For established methods such as dry heat, EO, steam, radiation, and vaporized hydrogen peroxide, there are voluntary consensus standards for development, validation, and routine control that are recognized by FDA.

  • Established Category B: In cases where FDA has previously evaluated sterilization development and validation data for specific sterilizers using discrete cycle parameters and determined the validation methods to be adequate, it is considered as Established Category B.

B. Novel Sterilization Methods: A Novel Sterilization Method is a method that FDA has not reviewed and determined to be adequate to effectively sterilize the device for its intended use.


To understand the requirements and to see more examples click this LINK.


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