FDA Allows Modification of Certain Ophthalmic Devices, Expanding Use for Telehealth and Remote Assessment
In the ongoing effort to reduce in-person contact and exposure during the coronavirus pandemic, this week FDA released the guidance document "Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (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 public health emergency. Coupled with the Office for Civil Rights' exercise of enforcement discretion 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.
Devices covered by the guidance include certain Class I and Class II devices that are exempt from premarket submission requirements (i.e., visual acuity charts, visual field testing devices, Amsler grids and ophthalmic cameras) that under normal circumstances might require a premarket submission for the permitted modifications (e.g., going from health care facility use only to home use) and Class II 510(k)-Cleared Tonometers, which measure intraocular pressure using a small flat disk applied to the cornea. The policy will allow certain limited modifications to the indications, functionality, hardware and/or software of 510(k)-Cleared Tonometers for remote assessment and monitoring of ophthalmic parameters, and distribution and use of exempt devices, without compliance with certain regulatory requirements. In each case, modifications will be permitted only where they do not create an undue risk in light of the public health emergency.
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. Examples of modifications to exempt devices that would not create undue risk include changing the indications for use and functionality to:
- Allow for monitoring and assessment of parameters
- Allow for home use by consumers
- Add wireless or Bluetooth capabilities
- Permit the use of the device for telemedicine
For 510(k)-Cleared Tonometers, FDA believes that an undue risk will not be created where:
- The device is intended only for measure intraocular pressure.
- The device is handheld or portable.
- The mechanism of measurement is either non-contact, rebound, or transpalperbral.
- The device is intended only to support or provide adjunctive recommendations to the eye care professional or patient.
- The eye care provider or patient can independently review the basis for any diagnostic or treatment recommendations.
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 information on the new guidance for ophthalmic assessment and monitoring devices, please contact Tricia Kaufman, Sheva Sanders, Joel Schwartz or the Stinson LLP contact with whom you regularly work.