FDA Classifies Corneal Storage Medium as Class II Device

FDA issued a final order classifying corneal storage medium with preservatives including antifungals as a Class II device. This liquid is used to temporarily preserve human cornea tissue between harvesting and implantation. The device was previously treated as Class III because it was not on the market before 1976. FDA reviewed the request and determined that special controls can provide reasonable assurance of safety, allowing the device to be moved to Class II.

Why it matters: This action removes the requirement for a full premarket approval application for corneal storage media with preservatives including antifungals. Manufacturers can now use the 510(k) process, which is generally less burdensome than the Class III pathway. This should reduce regulatory costs and time to market for these specific storage solutions, though the safety testing and labeling requirements remain in place.

Who it affects

• Manufacturers of corneal storage media with preservatives including antifungals

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The Food and Drug Administration issued this final order on May 2, 2022, and codified the classification in 21 CFR 886.4320. You should check the original Federal Register document for the complete text of the special controls and risk mitigation requirements.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document