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This document serves as a notification for the marketing of hydrophilic contact lenses under a special 510(k) premarket application, focusing on the parametric release from moist heat sterilization.

How to fill out bundled special 510k for

How to fill out Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses

1. Begin by gathering all necessary documents related to the product, including design specifications and sterilization validation data.
2. Complete the Form 3514 regarding your proposed device, ensuring it meets the requirements for a Special 510(k).
3. Provide a summary of the device’s intended use and description.
4. Include detailed information on the sterilization process, including parameters and equipment used in moist heat sterilization.
5. Present data demonstrating the product's safety and effectiveness, specifically regarding the parametric release methodology.
6. Include validation studies that confirm the sterilization process is effective and reliable for the specific contact lenses.
7. Ensure you follow the FDA's guidelines and format requirements for submitting a 510(k) application.
8. Review the application for completeness, sign, and submit it electronically through the FDA's submission portal.

Who needs Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

1. Manufacturers of soft hydrophilic daily wear contact lenses looking to utilize an alternative sterilization method.
2. Companies seeking FDA clearance for their devices meant to undergo moist heat sterilization with parametric release.
3. Any medical device organization that requires streamlined regulatory approval for their specific contact lens products.

For pdfFiller’s FAQs

What is Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

The Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses is a regulatory submission that allows manufacturers to demonstrate that their modifications to existing products meet the criteria for sterilization using moist heat, ensuring the lenses are safe and effective for wear.

Who is required to file Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

Manufacturers of soft hydrophilic daily wear contact lenses who intend to implement changes in their sterilization process to incorporate moist heat sterilization must file the Bundled Special 510(k).

How to fill out Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

To fill out the Bundled Special 510(k), manufacturers should follow the FDA guidelines, providing detailed information on product description, the changes being made, the parametric release process, sterilization validation data, and any necessary performance testing results.

What is the purpose of Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

The purpose is to streamline the regulatory process for manufacturers by allowing them to obtain clearance for significant changes in sterilization methods, ensuring ongoing safety and efficacy of the lenses without requiring a full 510(k) submission.

What information must be reported on Bundled Special 510(k) for Parametric Release from Moist Heat Sterilization for Soft Hydrophilic Daily Wear Contact Lenses?

The information to be reported includes the intended use of the lenses, detailed descriptions of the sterilization process and its validation, any changes made to the manufacturing process, data supporting the safety and effectiveness of the new sterilization method, and any clinical data if applicable.