Navigating the Latest FDA Guidelines for Sterility in Medical Devices - 510(k) Submissions

On January 8, 2024, the FDA introduced a revised guidance document titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." This document provides new recommendations and clarity on submitting sterilization information for medical devices labelled as sterile, replacing the 2016 version with significant updates to established sterilization methods.

Background

With the diversity of sterilization methods available for medical devices and the increasing number of 510(k) submissions featuring innovative technologies, the FDA recommendation aims to ensure the safety and effectiveness of the sterilization process used. Notably, the guidance recognizes non-traditional methods like vaporized hydrogen peroxide, ozone, and flexible bag systems as established methods.

Scope

The guidance focuses on devices undergoing industrial terminal sterilization processes based on microbial inactivation. Exclusions involve:

• Sterilizers as medical devices
• Processes relying on microbial exclusion
• Sterilization of devices with animal-origin materials
• Liquid chemical sterilant
• Single-use medical devices reprocessing

Methods of Sterilization

The document differentiates between sterilization methods and categorizes them as established and novel. Established methods include Category A, with a proven track record of safe use, and Category B, where the FDA has previously evaluated sterilization development and validation data. Novel methods cover newly developed techniques with limited published information or FDA evaluation.

Sterilization Information for Devices Labeled as Sterile

I. Established Sterilization Methods

For devices using established methods, sponsors must provide detailed information on the sterilization process, validation methods, sterilization site, radiation dose (if applicable), and residual levels of sterilants. Additionally, sponsors must address pyrogenicity testing, sterilization assurance levels, and packaging details.

II. Novel Sterilization Methods

Beyond established method requirements, when using novel sterilization methods, it will be necessary to submit comprehensive process descriptions, validation protocols, validation data, and relevant scientific literature. Even following these recommendations, the FDA could request additional information based on the specific device under review.

Main Takeaway

Medical device companies should closely follow FDA guidance on sterilization methods to ensure the effectiveness of sterilization processes for their devices. By adhering to these guidelines, companies can meet the necessary standards for sterilization, ensuring the safety and efficacy of their medical devices in healthcare settings.