FDA Reclassifies Ophthalmic Device

The FDA is reclassifying the diurnal pattern recorder system from Class III into Class II to mitigate ocular risks.

Effective May 31, any firm submitting a premarket notification for a diurnal pattern recorder system will need to comply with the special controls prior to marketing the device.

A diurnal pattern recorder system is a non-implantable device incorporating a telemetric sensor that detects changes in ocular pressure.

For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device.

Read the final order here: www.fdanews.com/06-02-16-DiurnalRecorderSystemClassification.pdf. — Joya Patel