FDA offers expanded use for ECMO, cardiopulmonary bypass and ophthalmic devices amid COVID-19

Regulatory NewsRegulatory News
| 07 April 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Monday issued guidance allowing for limited expanded use of extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices during the coronavirus disease (COVID-19) pandemic.
The agency also opened the door to expanded use for a range of ophthalmic assessment and monitoring devices to reduce the need for in-person visits to health care facilities during the outbreak.
ECMO and Cardiopulmonary Bypass Devices
According to FDA, long-term extracorporeal oxygenation is needed to treat some patients with COVID-19 who experience acute respiratory or cardiopulmonary failure.
FDA says it will not object to certain modifications to already cleared ECMO or cardiopulmonary bypass devices during the public health emergency without prior 510(k) notification to expand their availability and use, so long as the modifications do not pose an undue risk to patients.
While cardiopulmonary bypass devices function similarly to ECMO devices, they are regulated separately and cleared for six or fewer hours of use.
Under the new enforcement policy, FDA says it will allow modifications to cardiopulmonary bypass devices including changes to the device’s indications to include use in an ECMO circuit, to allow more than six hours use in an ECMO circuit and to allow modifications to accessories for both ECMO and cardiopulmonary bypass devices that do not affect the flow rate of blood through the circuit.
FDA says it considers certain modifications to pose an undue risk to patients, including changes to device coatings and changes that could negatively impact the gas transfer/exchange properties of the device.
The agency also provides labeling recommendations for devices modified under the policy and a set of FDA-recognized consensus standards for designing, evaluating and validating such modifications.
Additionally, FDA says it is interested in working with manufacturers to grant emergency use authorizations (EUAs) for ECMO and cardiopulmonary bypass devices that are not currently legally marketed in the US. In some instances, FDA says it will allow the distribution and use of a non-legally marketed device while the company is still preparing an EUA request.
FDA notes that the guidance does not apply to extracorporeal carbon dioxide removal devices “because such devices may not oxygenate the blood at clinically meaningful levels.” However, FDA says manufacturers of such devices may consider requesting an EUA.
Ophthalmic Devices
For ophthalmic devices, FDA says it will not object to a range of modifications without 510(k) notification for devices falling under seven product codes encompassing visual acuity charts, visual field devices, general use ophthalmic cameras and tonometers.
The permissible modifications under the policy are broken up by device type, with FDA providing a set of allowable modifications for visual acuity charts, visual field devices and general use ophthalmic cameras and a separate set of modifications for tonometers.
For all the devices aside from tonometers, FDA says allowable modifications under the policy include changes to the indications or functionality to allow for patient monitoring or assessment; home use by consumers; and remote assessment for telemedicine consultations.
FDA says the policy does not cover devices “intended to determine when patients need immediate clinical intervention to assure patient safety” or devices “intended to be solely or primarily relied upon by the eye care provider or patient to make a clinical diagnosis or treatment decision.”
For tonometers, FDA says that limited modifications may be permitted for devices that are only intended for measuring intraocular pressure; are handheld or portable; operate with a non-contact, rebound or transpalperbral mechanism; are intended for supporting or providing adjunctive recommendations to eye care providers; and “allow for eye care providers to independently review the basis for any diagnostic or treatment recommendations.”
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency


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