As US healthcare providers face shortages of medical devices and equipment during the COVID-19 pandemic, the Food and Drug Administration has moved to expedite market authorizations for certain products needed to address the public health emergency. Automotive and other manufacturers of non-medical products may also step in to help boost supplies of devices such as ventilators, but must first gain a better understanding of regulations and standards specific to medical devices.
Below, we examine how manufacturers may apply for FDA EUA designation for qualifying devices, as well as regulatory factors non-medical manufacturers should be aware of as they consider retooling their facilities to help address shortages of ventilators and other healthcare equipment.
FDA EUA criteria and submissions
First, FDA has issued Emergency Use Authorizations (EUA) for medical devices including IVD test kits to diagnose COVID-19 as well as personal protective equipment (PPE) such as filtering facepiece respirators needed to protect healthcare providers interacting with patients. In addition, FDA has issued final guidance on ventilator devices that facilitates EUA designations for these products to treat COVID-19 patients.
Under EUA declarations, FDA has the authority to authorize rapid emergency use of specific devices via expedited premarket review during public health crises such as the coronavirus pandemic.
Key criteria for obtaining an EUA designation from FDA include:
- Presence of a chemical, biological, radiological or nuclear agent (in this case, the coronavirus) that poses a serious disease or condition;
- Qualifying device must meet a “may be effective” standard for treating the targeted disease or condition (in this case, COVID-19), which entails a lower threshold of required evidence compared to FDA’s standard “effectiveness” criterion applied in normal premarket reviews;
- Ability of FDA’s part to determine via risk-benefit analysis the device’s known and potential benefits regarding treating, diagnosing or preventing COVID-19;
- Lack of adequate, FDA-approved/cleared or available alternative treatments.
Requesting an EUA designation
Manufacturers seeking EUAs for qualifying devices should first initiate “pre-EUA” activities and engagement with FDA to discuss potential designations. This step is particularly recommended for companies whose devices are in advanced stages of development, since rapid access to healthcare providers is crucial.
Next, a manufacturer should submit a formal EUA designation request to FDA. These submission should include as much safety, effectiveness and risk-related data as is available pertaining to the devices in question. The depth and breadth of such information will depend largely upon whether a device submitted for EUA consideration has already been cleared or approved for use by FDA, or if an EUA designation would entail using a previously cleared or approved device in a manner for which it was not intended.
Timelines for EUA submission reviews and determinations are made on a case-by-case basis, according to FDA, but the agency usually issues these designations “within hours or days” provided that manufacturers have met necessary criteria and engaged in adequate pre-EUA activities.
How long does an EUA designation last?
Although obtaining an EUA designation provides expedited access to the US healthcare market, such authorizations last only as long as the public health emergency for which they are granted by FDA. The agency determines effective dates of EUAs, and at the end of an EUA declaration period these individual authorizations are terminated. Manufacturers of EUA-designated devices that have not previously obtained FDA market authorization must then dispose of such devices still on the US market; for devices cleared or approved for other intended uses outside the scope of their EUAs, manufacturers must ensure that such devices return to “normal use.”
Considerations for non-medical manufacturers
In its recently released final guidance on oversight of ventilators and other respiratory devices in increasingly short supply in the US, FDA seeks to expand availability of these devices partially by making EUA designations available for qualifying companies—including those with limited to no previous experience manufacturing medical devices but interested in doing so to help alleviate shortages.
Notably, FDA strongly encourages non-medical manufacturers with the potential in increase ventilator and related device supplies to pursue EUA designations with the agency during the COVID-19 emergency. Interested companies should email FDA their proposed approaches to addressing supply shortages.
The final guidance also allows more flexibility for manufacturers to modify components or functions of ventilators without having to submit 510(k) premarket notifications to the agency for the duration of the COVID-19 emergency. Such an approach is intended to “help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply change interruptions and manufacturing bottlenecks,” according to the agency.
This approach opens the door for greater cooperation between the agency and automotive/industrial manufacturers with the capacity to ramp up production of needed devices but with less experience dealing with device-specific regulations and standards.
(Potentially) applicable FDA regulations and standards
Non-medical manufacturers should nonetheless be aware of quality, safety and performance standards FDA typically requires regarding production and modification of ventilator hardware, software and materials; automotive and industrial manufacturers may need to adjust processes and procedures to comply with these requirements. Pertinent standards in this regard include:
- The IEC 60601 group standards for medical electrical equipment;
- IEC 62304 for medical device software life cycle processes;
- ISO 10993 for biological evaluation of medical devices
- The ISO 80601 group of standards for medical electrical equipment including ventilators and respiratory devices
Companies should refer to the FDA final guidance document for a full list of applicable standards and regulations. Some of these requirements may not be fully enforced during a device’s EUA designation, but manufacturers interested in keeping their products on the US market over the longer term will eventually have to demonstrate full compliance.
Likely FDA conditions for granting EUAs to non-medical manufacturers
Even though EUA designation circumvents some standard FDA clearance or approval requirements, the agency does cite conditions that will likely need to be met in order to obtain such designations for much-needed ventilator and respiratory devices:
- Informing healthcare professionals as well as patients that FDA has authorized these devices for emergency use, and of available pertinent risk/benefit data;
- Establishing processes for monitoring and reporting of adverse events related to these devices’ emergency use;
- Maintaining adequate recordkeeping and reporting related to emergency use of these devices.