Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FINAL RULES: FDA reclassifies ophthalmic device, (May 20, 2024)

By WK Editorial Staff

The FDA issued a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification.

The FDA also established special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. The FDA is finalizing this reclassification on its own initiative based on valid scientific evidence. For this class II device, instead of a premarket approval application, manufacturers may submit a premarket notification, i.e., a 510(k) submission, and obtain FDA clearance of the device before marketing it (Final Rule, 89 Fed. Reg. 43743 (May 20, 2024)).

Dates. The order is effective June 20, 2024.

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