Jon Speer, Founder and VP of QA/RA at Greenlight Guru01.07.22
Yes, we should all realize that the FDA’s Emergency Use Authorization (EUA) for the medical device industry is definitely going to end sometime soon. No, I’m not able to tell you for certain or even predict with any accuracy as to exactly when.
Here is what I do know about the status of EUA. The FDA is starting to hint that an EUA transition will be happening before too long. FDA has stated that they expect there to be a gradual transition back to normal for medical devices in 2022. Additionally, the FDA recently published two draft guidances regarding COVID-19 transition:
Just in case you are not familiar, EUA is a provision that allows the FDA to help address public health against chemical, biological, radiological, nuclear, and infectious disease threats. Of course, the COVID-19 pandemic fits within the latter of these. And in March 2020, the HHS Secretary declared that COVID-19 had reached the point where implementing EUA became necessary. Without getting into all the technical details, EUA is a temporary regulatory pathway to authorize the use of drugs, biologics, medical devices, etc. to address needs of the pandemic.
Note the word authorize. Speaking for medical devices, there are typically 7 FDA pathways to bring a device to market. Without going through them all, the most common of these pathways is 510(k) clearance, premarket approval, and de novo granted. While it may seem a bit nitpicky, the differences between “clearance”, “approval”, and “granted” have very meaningful and important distinctions. And realize that an EUA is none of these pathways; it is a temporary authorization for use for a very specific use, in these times 100% specific to COVID-19.
With EUA, many of the typical expectations, regulations, and compliance requirements have either been lifted or much more lax than non-EUA processes. From an FDA FAQ page regarding COVID-19 EUA:
Specifically, note the underlined verbiage from the FDA. Also note that the intent behind EUA is to allow the FDA to authorize use of medical devices within weeks. The typical FDA regulatory pathways definitely take many months to several years.
Additionally, the barriers to entry for companies developing EUA products is much more lax as well. Typical activities such as documenting design controls for the development of a medical device, good manufacturing practices (GMPs), post-market surveillance, and quality system requirements are waived for EUAs.
Personally, I have some mixed feelings about the overall EUA process. On one hand, it is encouraging that the FDA is able to institute a fast path to get products into the marketplace that address an immediate health need. On the other hand, is it a good idea to remove the majority of medical device regulations for EUAs with no requirement or plan to address these?
One other thing that is somewhat irksome with respect to EUAs, at least to me: I’ve heard quite a few folks in the media make statements about EUAs being just as safe and effective as non-EUA medical devices. This is just not a true statement across the board. I’m sure there are plenty of EUAs which are just as safe. And I’m also 100% sure there are hundreds of EUAs that can not make these sorts of claims. Why not? Remember, EUAs are not required to demonstrate the same level of safety and efficacy.
It’s been known since day one of EUA that these device market authorizations would be temporary and only applicable until HHS Secretary deems otherwise. It also should be known that if a company with EUA products plans to continue to sell and market the devices after the EUA termination date, that they must prepare traditional regulatory submissions (e.g. de novo, 510(k), PMA) and receive the appropriate permission from the FDA to keep the products on the market. Additionally, EUA product companies must address the previously relaxed regulations for design controls, GMPs, post-market surveillance, and quality systems.
Yes, the FDA has stated there will be a 6-month transition from when FDA announces the “EUA termination date.” However, if a company waits until the FDA announces the EUA termination date, six months will not be enough time for the company to do what is required to keep the products on the market. Simple translation: EUA devices that have not been "converted" to traditional medical devices via traditional regulatory pathways will need to be removed from the market.
And there have been several hundred EUAs authorized by the FDA. Hundreds!
At the time of this post, the FDA has not yet announced the EUA termination date. So, you have in excess of six months to take action and address the normal medical device regulatory expectations.
My first piece of advice is that you conduct a gap analysis of your current EUA product and related documentation against what would typically be required for this type of medical device. Identifying the gaps will help determine what work will be required. The results of a gap analysis should help inform your regulatory strategy. For example, what regulatory pathway(s) should you pursue and why? More specifically: Should you pursue a de novo for your product? Or maybe a 510(k)? (Hopefully you get the point.)
Understanding the gaps and devising your regulatory strategy is key because it will help you determine what you need to do and provide a relative idea of the timeline to address the needs.
Let me try a paint an even more specific picture of you. The majority of medical devices in the U.S. are Class II and require a 510(k) submission and market clearance from FDA. A typical timeline for receiving 510(k) market clearance is roughly six to nine months from after the date you submit it to the FDA. To get a device to the point of being ready for a 510(k) submission can easily be years.
I’ve also heard some anecdotes from colleagues and consultants that they have clients with EUA products who are simply planning to submit the same data and information for their product that they used for their EUA submission. Let me be blunt: This is not going to pass muster. This is a terrible approach and plan. Your EUA was specific to a COVID-19 indication. Upon EUA termination date, your product indications must be different than COVID-19 specific.
If you have EUA products in the market, you may have read my thoughts as a sort of doom and gloom. My purpose for writing this is to help articulate, illustrate, and educate you on some of what you need to know and be doing to continue selling your EUA products after the EUA termination date.
Remember, too, that if you have not established a quality management system (QMS) that complies with FDA 21 CFR Part 820, then this is also mission critical for your company.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru a medical device quality management MDQMS software & a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
Here is what I do know about the status of EUA. The FDA is starting to hint that an EUA transition will be happening before too long. FDA has stated that they expect there to be a gradual transition back to normal for medical devices in 2022. Additionally, the FDA recently published two draft guidances regarding COVID-19 transition:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Just in case you are not familiar, EUA is a provision that allows the FDA to help address public health against chemical, biological, radiological, nuclear, and infectious disease threats. Of course, the COVID-19 pandemic fits within the latter of these. And in March 2020, the HHS Secretary declared that COVID-19 had reached the point where implementing EUA became necessary. Without getting into all the technical details, EUA is a temporary regulatory pathway to authorize the use of drugs, biologics, medical devices, etc. to address needs of the pandemic.
Note the word authorize. Speaking for medical devices, there are typically 7 FDA pathways to bring a device to market. Without going through them all, the most common of these pathways is 510(k) clearance, premarket approval, and de novo granted. While it may seem a bit nitpicky, the differences between “clearance”, “approval”, and “granted” have very meaningful and important distinctions. And realize that an EUA is none of these pathways; it is a temporary authorization for use for a very specific use, in these times 100% specific to COVID-19.
With EUA, many of the typical expectations, regulations, and compliance requirements have either been lifted or much more lax than non-EUA processes. From an FDA FAQ page regarding COVID-19 EUA:
- What is an emergency use authorization and how is being used to respond to COVID-19?
- In certain types of emergencies, the FDA can issue an emergency use authorization, or EUA, to provide more timely access to critical medical products (including medicines and tests) that may help during the emergency when there are no adequate, approved, and available alternative options.
- The EUA process is different than FDA approval, clearance, or licensing because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks rather than months to years.
- EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency and new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.
Specifically, note the underlined verbiage from the FDA. Also note that the intent behind EUA is to allow the FDA to authorize use of medical devices within weeks. The typical FDA regulatory pathways definitely take many months to several years.
Additionally, the barriers to entry for companies developing EUA products is much more lax as well. Typical activities such as documenting design controls for the development of a medical device, good manufacturing practices (GMPs), post-market surveillance, and quality system requirements are waived for EUAs.
Personally, I have some mixed feelings about the overall EUA process. On one hand, it is encouraging that the FDA is able to institute a fast path to get products into the marketplace that address an immediate health need. On the other hand, is it a good idea to remove the majority of medical device regulations for EUAs with no requirement or plan to address these?
One other thing that is somewhat irksome with respect to EUAs, at least to me: I’ve heard quite a few folks in the media make statements about EUAs being just as safe and effective as non-EUA medical devices. This is just not a true statement across the board. I’m sure there are plenty of EUAs which are just as safe. And I’m also 100% sure there are hundreds of EUAs that can not make these sorts of claims. Why not? Remember, EUAs are not required to demonstrate the same level of safety and efficacy.
It’s been known since day one of EUA that these device market authorizations would be temporary and only applicable until HHS Secretary deems otherwise. It also should be known that if a company with EUA products plans to continue to sell and market the devices after the EUA termination date, that they must prepare traditional regulatory submissions (e.g. de novo, 510(k), PMA) and receive the appropriate permission from the FDA to keep the products on the market. Additionally, EUA product companies must address the previously relaxed regulations for design controls, GMPs, post-market surveillance, and quality systems.
Yes, the FDA has stated there will be a 6-month transition from when FDA announces the “EUA termination date.” However, if a company waits until the FDA announces the EUA termination date, six months will not be enough time for the company to do what is required to keep the products on the market. Simple translation: EUA devices that have not been "converted" to traditional medical devices via traditional regulatory pathways will need to be removed from the market.
And there have been several hundred EUAs authorized by the FDA. Hundreds!
What to Do if You’re a Company with EUA Products
What if you are a company with EUA products? What should you be doing now?At the time of this post, the FDA has not yet announced the EUA termination date. So, you have in excess of six months to take action and address the normal medical device regulatory expectations.
My first piece of advice is that you conduct a gap analysis of your current EUA product and related documentation against what would typically be required for this type of medical device. Identifying the gaps will help determine what work will be required. The results of a gap analysis should help inform your regulatory strategy. For example, what regulatory pathway(s) should you pursue and why? More specifically: Should you pursue a de novo for your product? Or maybe a 510(k)? (Hopefully you get the point.)
Understanding the gaps and devising your regulatory strategy is key because it will help you determine what you need to do and provide a relative idea of the timeline to address the needs.
Let me try a paint an even more specific picture of you. The majority of medical devices in the U.S. are Class II and require a 510(k) submission and market clearance from FDA. A typical timeline for receiving 510(k) market clearance is roughly six to nine months from after the date you submit it to the FDA. To get a device to the point of being ready for a 510(k) submission can easily be years.
I’ve also heard some anecdotes from colleagues and consultants that they have clients with EUA products who are simply planning to submit the same data and information for their product that they used for their EUA submission. Let me be blunt: This is not going to pass muster. This is a terrible approach and plan. Your EUA was specific to a COVID-19 indication. Upon EUA termination date, your product indications must be different than COVID-19 specific.
If you have EUA products in the market, you may have read my thoughts as a sort of doom and gloom. My purpose for writing this is to help articulate, illustrate, and educate you on some of what you need to know and be doing to continue selling your EUA products after the EUA termination date.
Remember, too, that if you have not established a quality management system (QMS) that complies with FDA 21 CFR Part 820, then this is also mission critical for your company.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru a medical device quality management MDQMS software & a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
