Regulatory Focus™ > News Articles > Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting

Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting

Posted 12 September 2012 | By Alexander Gaffney, RAC 

Officials from the US Food and Drug Administration (FDA) are planning to hold a workshop in October to study the use, validity and reliability of medical devices used to image glaucomas, the agency announced in a Federal Register posting.

A glaucoma is a type of eye disorder that negatively affects the optic nerve, usually because of increased pressure on the nerve, which can lead to worsened vision or blindness. In recent years, imaging devices have come to define new standards of care for glaucoma patients thanks to advances in device hardware and software, but questions persist about the safety and validity of some of them.

FDA's workshop, jointly sponsored with the American Glaucoma Society, aims to address some of these questions. In particular, the workshop will discuss devices used to image the posterior segment of the eye using Optical Coherence Tomography (OCT), "With particular emphasis on normative databases and the diagnostic performance of OCT for therapeutic glaucoma products (regulatory considerations) and clinical decision making," FDA wrote.

The regulatory considerations discussed at the meeting are likely to include the, "Optimal endpoints and strategies for assessing the safety and effectiveness of these new diagnostic tools," said FDA, as well as validation approaches and the impact of databases on the use of OCT devices.

The meeting will be held on 5 October 2012 at FDA's White Oak Campus in Silver Spring, MD.


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