Part 5: FDA Remote Ophthalmic Assessment Guidance | COVID-19

 

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?

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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Gregory House spearheads innovation and technology at Syncro through exciting new initiatives. Greg earned a PhD in Electrical and Computer Engineer from Carnegie Mellon University and has a 20-year track record of commercializing digital technologies. He was Principal Investigator for $2 million in biomedical funding, awarded 11 US patents, and published 8 peer reviewed journal articles. His hands-on experience includes driving intellectual property strategy, building multi-disciplinary engineering and operation teams, and collaborating with research and medical institutions. Greg launched innovative products for health care and sports media into demanding real-world environments. He enjoys outdoor nature activities and serving the elderly and the community.

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