ECMO Bypass Device Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 ECMO Bypass Devices guidance?
- COVID-19 can trigger acute respiratory failure and/or acute cardiopulmonary failure.
- Extracorporeal oxygenation for greater than 6 hours may be essential treatment.
- Modified Cardiopulmonary bypass (CPB) devices may expand availability of EMCO therapy.
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 kind of modifications are envisioned by this guidance?
- Update CPB device indications to include use in an ECMO circuit to treat patients who are experiencing acute respiratory failure and/or acute cardiopulmonary failure;
- Update CPB device indications to include for longer than 6 hours of use in an ECMO circuit; or
- For CPB and ECMO devices, enable dimension changes to accessories (cannulae, tubing, filters, or connectors) that do not affect the flow rate of blood throughout the ECMO circuit.
What kind of modifications are not covered by this guidance?
- Changes to the coating of the device; or
- Changes that could negatively impact gas transfer/exchange, such as the dimension of gas exchange fiber, type of gas exchange fiber, or the surface area of the fiber mat.
What are expected labeling updates?
- Describe ECMO data on device performance, durability/clinical testing, and potential risks.
- Display exhaustive list of clinical signs that suggest device change-out is necessary.
- Include information on use conditions;
- Delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Provide a general statement that changes have not been cleared or approved by FDA.
What is the envisioned validation of COVID-19 changes?
- Designing, evaluating, and validating modifications should be done according to FDA recognized standards.
What needs to be submitted for Emergency Use Authorization of international devices?
- Manufacturer contact information and copy of the product labeling.
- Whether the device currently has marketing authorization in another regulatory jurisdiction.
- A summary of performance data available for long term use of the device.
- Whether the device is designed, evaluated, and validated by FDA recognized standards.
- Whether the device is designed with a U.S. compatible power supply.
- Whether device manufacture complies with FDA Medical Devices Quality Management Systems.
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