FDA Issues Guidelines for Remote Ophthalmic Testing and Monitoring

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SILVER SPRING, Md.—The Food and Drug Administration (FDA) yesterday issued new, temporary guidelines for remote ophthalmic assessment and monitoring devices during the coronavirus disease crisis. The guidelines, which are voluntary and non-binding, cover diagnostic devices such as visual acuity charts, visual field devices and general-use ophthalmic cameras and tonometers. The purpose of the guidelines is “provide a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and health care provider contact and exposure to COVID-19 during this pandemic,” according to the FDA.

“Certain of these devices are not approved for home use,” noted John Rumpakis, OD, founder and CEO of Practice Resource Management, Inc. and clinical coding editor for Review of Optometry. “The FDA is trying to make some of them available as long as they don’t pose additional harm to the patient. For example, if there was a methodology to allow a patient to take their visual acuity or measure their visual field at home, that would be OK under the guidelines,”

The FDA guidelines include devices that “have the potential to be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection to transmit a patient’s ophthalmic parameters directly to their eyecare provider or other monitoring entity.” The agency noted that some devices also have the potential to “apply algorithms to transform a patient’s ophthalmic parameters into a novel index or alarm that may aid an eyecare provider in the diagnosis of a particular condition or disease state/severity or be used in the context of a telemedicine visit, with the patient at home, allowing the eyecare provider to assess specific ophthalmic parameters remotely.”

According to the FDA, the guidelines cover devices previously intended for use in health care facilities as well as modifications of non-portable devices that may now include portable or handheld device features. Modifications to devices, including changes in hardware or software, are also allowed for virtual reality or mobile technology for remote assessment or monitoring capability.

The FDA specified that tonometers may be modified only for the purpose of measuring intraocular pressure, if the device is handheld or portable and if the mechanism of measurement is either non-contact, rebound, or through the eyelid.

Diagnostic device makers, software developers, suppliers and eyecare professionals and industry analysts are now interpreting the guidelines to determine how they apply to their products.

A spokesperson for Carl Zeiss Meditec told VMAIL, “The FDA guidance expands the usability of these classes of devices to the patient, and provides greater latitude for telemedicine and remote assessment. Carl Zeiss Meditec, Inc. will consider these use cases as we look to provide for our customers and their patients during this crisis. We are dedicated to exploring ways to increase the availability of ophthalmic assessment to patients in need and are actively evaluating ways to broaden the reach for our customers to allow greater access to their patients.”

Because of the public health emergency, FDA said the guidance is being implemented without prior public comment.