Remote Ophthalmic Assessment Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 ECMO Bypass Devices guidance?
- Remote connectivity and analysis would facilitate telemedicine treatment of patients.
- Modified Ophthalmic devices may be able transmit patient parameters to providers remotely.
- Some devices may be able to analyze parameters and alert providers to disease state/severity.
What medical device types are covered by this guidance?
- Visual acuity charts, visual field devices, and ophthalmic cameras enable eye assessment or imaging for detection or monitoring the progression of ocular conditions or diseases.
- Tonometers measure intraocular pressure.
What related devices are not covered by the guidance?
- Extracorporeal carbon dioxide removal devices as may not oxygenate blood at clinically meaningful levels. However, an Emergency Use Authorization potentially can be pursued.
What are acceptable modifications to Table 1: Visual Devices?
- New Indications and functionality for monitoring/assessment of the ophthalmic parameters.
- New Indications and functionality for home use and/or by consumers.
- New Indications and functionality for telemedicine remote consultation.
- Hardware/Software changes for use directly by consumers at home.
- Hardware/Software changes to facilitate remote access.
- Hardware/Software changes including virtual reality or mobile technology.
What are acceptable modifications to indications or functionality of Table 2: Tonometers?
- The intended use of the device is to measure intraocular pressure;
- The device is portable or handheld;
- The mechanism of measurement is either transpalperbral, rebound or non-contact;
- The provides adjunctive recommendations about prevention, diagnosis or treatment; and
- The basis for any diagnostic or treatment recommendations can be reviewed independently.
- The device determines when patients need immediate clinical intervention to assure patient safety.
- The device is intended to be solely or primarily relied upon for diagnosis or treatment decisions.
- Adding functionality to acquire/analyze signals not present in the FDA-cleared Tonometer device.
- Changes are made to Tonometer components that have direct contact with the eye.
What is the envisioned validation of COVID-19 changes?
- Designing, evaluating, and validating changes made to hardware, software, materials or duration of use should be done according to FDA recognized standards.
What are expected label updates?
- Describe data on device performance, and potential risks for new indications or functions.
- Provide adequate instructions for use, intended user and indicated use environment(s).
- Include basis for independent review of any diagnostic/treatment recommendations.
- Provide adequate lay instructions if device usage is expanding to include home settings.
- Delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Include disclaimer that device recommendations should not be solely or primarily relied upon.
Comments are closed.