FDA Allows Modification of Certain Ophthalmic Devices
In the ongoing effort to reduce in-person contact and exposure during the coronavirus pandemic, FDA released the guidance document “Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease (COVID-19) Public Health Emergency,” which outlines the agency’s temporary policy to allow certain modifications to ophthalmic assessment and monitoring devices, and expand their capabilities for remote health care.
As with other recent FDA policies to address the crisis, FDA intends that this policy will remain in effect only for the duration of the COVID-19. during the pandemic to allow use of non-public facing platforms that may not be compliant with HIPAA, such as FaceTime, Zoom or Skype, for telehealth visits, the FDA policy helps expand the availability of health care services that can be offered on a remote basis and in the home. As FDA continues to search for ways through limited device modifications to accommodate the need for social distancing, without compromising patient safety, it seems likely that similar policies in other specialty areas, for instance audiology, may be seen in the near future.
The guidance covers certain ophthalmic devices that assess or monitor ophthalmic parameters and that have the potential to connect to a wireless network to transmit data directly to an eye care provider or monitoring entity. Covered devices also may have the potential to apply algorithms to transform parameters into a novel index or alarm to aid in diagnosis or determine severity of a disease or condition or to help assess specific parameters remotely during a telemedicine visit from the patient’s home.
The guidance provides examples in each category of modifications that FDA believes would or would not create undue risk, lists applicable guidance documents and standards for validation of hardware and software modifications, and sets forth recommendations for labeling of the modified devices.
In each case, FDA believes undue risk would be created if the device is intended to determine when immediate clinical intervention is required or is intended to be primarily or solely relied upon by the user to make diagnosis or treatment decisions. In addition, for Tonometers, undue risk would be created by adding the functionality to acquire, process or analyze a pattern or signal from a signal acquisition system that was not present in the FDA-cleared device; or modifying the direct eye-contact components.
With respect to labeling, the guidance provides several recommendations, which should be carefully reviewed, aimed at helping consumers and health care providers understand the modifications and their functionalities, risks and limits, and provide adequate directions for use.
For more details: https://www.fda.gov/media/136733/download