Federal Register #2026-08813

FDA Classifies Corneal Storage Medium with Preservatives as Class II Medical Device

The Food and Drug Administration (FDA) has issued a final order regarding the regulatory classification of a specific medical device: - The device is a corneal storage medium with preservatives, including antifungals, used to temporarily preserve human cornea tissue between harvesting and implantation. - The FDA classifies this device as a Class II medical device with special controls to ensure safety and effectiveness. - Special controls required include: - Non-clinical performance testing - Sterility validation - Biocompatibility assessment - Shelf life support - Packaging compatibility - Antimicrobial resistance analysis - Specific labeling requirements - No procurement, solicitation, or acquisition of products or services is included in this notice. - No specific OEMs, vendors, or product part numbers are mentioned. - The notice is regulatory in nature and does not request proposals or bids.

Description

The Food and Drug Administration (FDA) is classifying the corneal storage medium with preservatives including antifungals into class II (special controls). This device is used to temporarily preserve human cornea tissue between harvesting and implantation. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens. Special controls include non-clinical performance testing, sterility demonstration, biocompatibility, shelf life support, packaging compatibility, antimicrobial resistance analysis, and specific labeling instructions.

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