Corneal Storage Fluid with Fungus Fighters Reclassified
Published Date: 5/6/2026
Rule
Summary
The FDA is officially putting corneal storage fluids with preservatives and antifungals into a safer, easier-to-manage category called Class II. This change helps make sure these eye care products are safe and effective while speeding up access to new, helpful devices. Starting May 6, 2026, companies will follow these new rules, which could save time and money by cutting down on red tape.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Class II listing may speed patient access
The FDA officially classified corneal storage medium with preservatives including antifungals as Class II (special controls). This change is effective May 6, 2026 (and was applicable May 2, 2022) and the agency says the change will enhance patients' access to beneficial innovative devices by reducing regulatory burdens while providing reasonable assurance of safety and effectiveness.
Manufacturers must meet special controls and 510(k)
Corneal storage media with preservatives including antifungals are Class II devices and therefore subject to premarket notification under section 510(k). Manufacturers must comply with the listed special controls (for example: non-clinical performance testing, sterility demonstration, biocompatibility, shelf life testing, packaging compatibility, antimicrobial resistance analysis, and labeling), so companies will need to perform these tests and include required information when seeking market clearance.
Creates a predicate for future devices
FDA states that when it classifies a device into Class II via the De Novo process, the device can serve as a predicate for future devices of that type, allowing other sponsors to use the less-burdensome 510(k) process rather than De Novo or premarket approval. This makes it easier for subsequent corneal storage media products to seek market clearance using the 510(k) pathway.
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