Remote Ophthalmic Assessment Guidance

Navigating the Regulatory Pathway during a Global Pandemic

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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.

What are unacceptable modifications to indications or functionality of Tables 1 or 2 devices?

• • 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.

 

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