Ventilators & Other Respiratory Devices Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Ventilators & Other Respiratory Devices guidance?
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- COVID-19 affected patients may develop respiratory failure or respiratory insufficiency;
- It is necessary to maintain an adequate supply of devices to treat these patients.
What medical device types are covered by the guidance?
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- The 13 devices and accessories covered provide ventilation and ventilatory support to patients with respiratory failure or respiratory insufficiency.
What type of modifications are envisioned?
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- Changes to the ventilator motor allowing an alternate supplier to meet design specifications.
- Changes to the material in the ventilator tubing enabling more flexible material sourcing.
What are permitted modifications to indications, claims or functionality?
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- Using powered emergency ventilators and anesthesia gas machines for mechanical ventilation.
- Using ventilators outside their cleared use environment (healthcare facility, transport, or home).
- Treat patients with respiratory insufficiency using appropriately modified sleep apnea devices.
- Oxygen concentrators use as primary supply if medically necessary or appropriate.
What are permitted hardware, software and materials changes?
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- Changes to motors, batteries, or other electrical components.
- Changing materials of components in the gas pathway or other patient tissue contact.
- Minimize aerosolization by introducing filtration (sleep apnea device).
- Software changes modifying ventilation parameters in accordance with any applicable standard.
- Software oxygen titration changes for devices with Investigational Device Exemption (IDE).
- Hardware/software modifications for remote ventilator parameter monitoring/adjustment.
What permitted changes around shelf life and duration of use?
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- FDA permits extending the shelf life and use duration of 13 breathing circuit supplies provided in accordance to healthcare institutional protocols so not to create undue risk.
What is envisioned validation of COVID-19 changes?
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- Designing, evaluating, and validating changes made to hardware, software, materials or duration of use should be done according to FDA recognized standards.
What COVID-19 labeling updates does the FDA recommend?
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- Describe device, performance and potential risks for new indications, claims, or functions.
- Distinctly delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Provide adequate instructions for use by intended user in indicated environment(s), including mitigation of any known risks associated with differences from FDA-cleared operation.
What needs to be submitted for Emergency Use Authorization of international devices?
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- 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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