Apr 5, 2021

The US Food and Drug Administration (FDA) has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health emergency. Medical device types covered include personal protective equipment (gloves, masks, etc.), certain remote assessment and monitoring devices, ventilators, sterilizers, disinfectants, infusion pumps, thermometers and telethermographic systems, digital health devices for treating psychiatric disorders, and diagnostic tests for COVID-19.

The EUA route is intended to provide an expedited route to the US market for devices that could help address the public health emergency. The FDA has not published specific timeframe expectations for these applications, and in Emergo’s experience, the time to authorization is highly variable, and has generally increased with the duration of the public health emergency.

Scaled-back EUA routes for some devices

The FDA appears to be winding down its EUA market access route for some medical devices. As the regulator has finite resources, this allows it to focus those resources on standard agency activities, such as reviewing 510(k) submissions and premarket applications (PMAs) required to obtain standard US market access for medical devices.

In some cases, this scaling back of EUA designations appears to be because the FDA has determined that there is now an adequate supply of those devices in the US for use during the public health emergency. As nationwide vaccination efforts begin to take effect, there may also be less demand for some of these devices.

Notable device-specific updates

Respirator Devices (N95s)

As Emergo by UL previously reported, FDA recently revised and reissued an “umbrella” EUA for imported respirator devices that lack approval from the National Institute for Occupational Safety and Health (NIOSH) to remove any criteria for new devices to be added to this EUA and therefore obtain market access for their devices. Market applicants seeking EUAs for such devices have been advised that they should consider 510(k) premarket notification going forward. This could prove difficult, as respirator devices are jointly regulated by NIOSH and the FDA, with applicants expected to first obtain approval from NIOSH and only then submit a 510(k) for a respirator, if applicable. It is Emergo’s understanding that NIOSH is currently several months behind on reviewing such applications, meaning that new market applicants are looking at delays that could extend a year or more between NIOSH and FDA.

(Note that certain updates, such as adding an initial importer, are still being reviewed by FDA for applicants that already have a respirator covered by this EUA, but not the addition of new models.)

Ventilators and COVID-19 Diagnostic Tests

Emergo by UL consultants report that since the start of 2021, they have seen FDA decline to review EUA submissions for some ventilator and COVID-19 diagnostic test devices. FDA has noted that the agency does not foresee an ongoing need to authorize more devices of these types unless they present clear advantages over products already available on the US market.  In these cases, FDA has recommended standard premarket submission routes including 510(k)s.

Fewer EUA authorizations likely for 2021

Now that several EUAs have been authorized by FDA for COVID-19 vaccines, approximately 153,000,000 vaccine doses have been administered, and 17% of the US population has been vaccinated as of April 1, 2021. Emergo believes that FDA will continue to scale down the number of EUAs that the regulator will review and authorize this year.

Learn how medical device markets are reacting to COVID-19

Considerations and recommendations for manufacturers of medical devices

EUAs are based on the US Secretary of the Department of Health and Human Services (HHS) determining that circumstances exist to justify the authorization of devices using alternative market access routes rather than the standard FDA routes. (See here for our initial coverage of FDA EUA processes from March 2020.) The current expectation is that EUA-authorized devices will remain in place for the duration of the public health emergency. The White House believes that the US will have enough vaccines to inoculate every American adult by the end of May 2021, although administration and dispensation of vaccines could take longer. It therefore seems likely that the public health emergency will be determined over sometime later in 2021.

Manufacturers that have submitted an EUA request for their device should be aware that FDA may decline to review their EUA, instead indicating the use of standard routes to market. Additionally, in certain cases when FDA has updated expectations, even manufacturers with applications that were compliant to requirements when submitted were informed that additional information would be needed, or that the device would not be authorized under an EUA. As this can happen without prior notice, manufacturers who are preparing submissions for EUAs should consider if this is the best pathway or if they should instead utilize the standard market access route.

Maintaining US market access after EUA authorizations expire

Manufacturers of devices that are currently EUA-authorized or under enforcement discretion in relationship to COVID-19 should consider what the standard route to market is for their device and determine if they wish to remain on the US market. If so, plans for continued market access should be made as soon as possible to avoid a possible interruption in their ability to supply such devices in the US.

FDA 510(k) considerations and timelines

Most devices that have EUA designations would usually require a 510(k). A typical 510(k) time to clearance from when it is submitted to the FDA is four to six months. If a company were to submit a 510(k) immediately, it is likely they would receive clearance sometime between August and October 2021.

It should be noted that some device types that have been allowed in the US under enforcement discretion or EUA authorization in relationship to COVID-19 have been identified for review by the FDA to determine if 510(k) clearance should still be required for these devices in the future. FDA intends to make final decisions for the standard route to market for these devices in May 2021. Manufacturers of devices in these categories may find it beneficial to wait until the agency announces its determination before compiling and submitting a 510(k) application.

For manufacturers who are considering submitting an EUA for their device, Emergo recommends carefully considering if this route to market best suits their needs. Such manufacturers should consider the following factors:

  • Many relatively recently submitted EUAs are taking months for FDA to authorize;
  • The end of the COVID-19 public health emergency may occur in the foreseeable future; and
  • Such authorizations are expected to end when the public health emergency is declared over.

Emergo believes that in many cases utilizing the standard route to market, often a 510(k) submission, is likely to better meet the needs of the manufacturer. Of course, this decision should be made on an individual basis by the manufacturer based on their unique circumstances. If the EUA route is utilized, a clear justification for the advantages of the product compared to those already on the market is highly recommended to minimize chances that FDA may decline to review the EUA.

Sarah Fitzgerald, RAC is Senior Consultant, Quality and Regulatory Affairs at Emergo by UL.

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  • Sarah Fitzgerald and Stewart Eisenhart