Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
Information
Type
Proposed Rule
Regulated products
Published
September 25, 2018
Last updated
September 25, 2018
Description
Document number 2018-20763. The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the ultrasound cyclodestructive device, a postamendments class III device (regulated under product code LZR), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these devices from class III to class II (special controls) and reduce regulatory burdens as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)