Regulatory Background
The document issued by the FDA is intended to provide industry representatives with the additional information related to the special approach to the regulation of ventilators and other respiratory devices during the public health emergency caused by the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. This situation led to the significant increase in demand for ventilators, accessories and other respiratory equipment needed by healthcare institutions to deal with the consequences of the disease.
Due to the urgency of the matter, the present guidance should be implemented immediately without prior public consultations. At the same time, industry representatives are still allowed to submit their comments and suggestions.
The Agency intends to expand the availability of the devices covered by the scope of the guidance due to the significant importance of such devices during the pandemic since the disease often leads to respiratory illness. For this purpose, the Agency introduces a special regulatory framework to simplify the procedures and reduce the regulatory burden to accelerate placing such devices on the market and making them available for healthcare facilities. It is also important to mention that the validity of the new framework should not exceed the public health emergency declared due to the COVID-19 outbreak.
Regulatory Requirements for Modifications
The guidance describes the requirements applicable to the modifications made to the ventilators, anesthesia gas machines and other respiratory devices already approved by the FDA.
The Agency advises healthcare institutions to use the device already approved by the FDA and allowed to be placed on the market, or the devices made available under the Emergency Use Authorization (EUA), a special regulatory framework intended to accelerate making the devices available during the public health emergency. At the same time, to expand the scope of the devices available, the Agency states that during the pandemic it would not object to certain modifications to the approved devices. In particular, the modifications falling within the scope of the aforementioned exclusion announced by the FDA include, inter alia, modifications to:
- Claims made by the manufacturer regarding the device,
- Indications for use,
- The functionality of the device,
- Hardware or software,
- Materials the device is composed of.
According to the guidance, the manufacturers would not need to submit 510(k) premarket notification that is required under the general rules in case of changes to the design of the device, its composition, source of energy used or to the manufacturing process.
By issuing the document the FDA intends to provide medical device manufacturers with the additional flexibility, allowing them to improve their devices by making such modifications as changes to the motor of the ventilator allowing the use of components provided by other suppliers, or changes to the materials used for the tubing of the ventilator to provide additional flexibility in raw material supply too. These measures are implemented to allow medical device manufacturers to engage additional production sites and expand the use of raw materials and components provided by other suppliers increasing the production of the devices to meet significant demand they face.
The approach to the modifications the Agency utilizes is based on the risk associated with such modifications. Thus, the FDA determines the cases when it will be acceptable to use the devices subject to modifications, namely:
- Using the emergency ventilators and anesthesia gas machines for the intended purpose,
- Using the ventilators beyond the approved environment of use,
- Using the devices initially intended to be used in case of sleep apnea when treating the patients with respiratory insufficiency (in case if all appropriate mitigations are made),
- Using oxygen concentrators.
The Agency also provides examples of modifications that do not result in increased risk for the patients. Such modifications, inter alia, include:
- Changes to electrical components, such as motors or batteries,
- Changes to the materials of components, including patient-contacting ones,
- Implementation of filtration elements,
- Modifications to the software operating the device in order to amend ventilation parameters,
- Modifications to the software introducing additional algorithms for oxygen titration,
- Modifications to the hardware and/or software of the device adding the functions of remote monitoring and adjustment of parameters used by the device.
The authority also emphasizes that in case of changes implementing remote monitoring and control features, the manufacturer should also develop and implement proper cybersecurity measures necessary to ensure the highest level of protection against third-party interferences in operations of the device, and also to identify and mitigate existing vulnerabilities.
Additional Exclusions and Validation of Changes
In order to extend the scope of the devices that could be available to healthcare institutions treating patients with the COVID-19 and respiratory illnesses it could lead to, the Agency will not object against amendments to the shelf life and duration of use as indicated by the manufacturer for the devices covered by the guidance. The authority states that such medical devices could be used longer than initially determined by the manufacturers in case if being used strictly in accordance with the applicable protocols while the useful life should be limited to the events of malfunction or soiling of the device that is clearly visible.
The Agency also emphasizes that all changes made to the device, including modifications to hardware, software or raw materials used should comply with applicable device-specific standards recognized by the regulating authority. The manufacturers should also duly document all modifications of the devices. The information on changes should be provided to the authority immediately upon demand.
The document also provides additional requirements on the labeling of medical devices subject to modifications. In accordance with these requirements, the labeling should contain:
- A detailed description of the amended claims, indications for use or functions, and also the information on the performance of the device and potential risks associated with its use,
- Clear instructions for use and indications regarding the environment of use,
- The visible distinction between the claims and indications approved by the FDA and ones added later.
The labeling should contain the information allowing to identify differences compared to the version of the same device approved by the regulating authority, and also the information about the ways to mitigate additional risks arising as the result of such modifications. It is also advised to supplement the information placed in the labeling with the statement providing that the changes made to the device have not been approved by the FDA, and also to provide an exhaustive description of such changes.
Summarizing the information provided hereabove, the Agency introduces simplified procedures to assist medical device manufacturers in meeting the increasing demand caused by the COVID-19 outbreak. In particular, the document describes the scope of modifications and improvements that could be made to the devices previously approved by the authority.
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