FDA EUA Premarket Submissions

FDA Announcements & Town Hall Meeting Summaries

From the weekly Town Hall Meetings hosted by the US FDA, our team translates and condenses the important points and guidances to provide an efficient way to keep you up-to-date.

FDA Encourages EUAs to Pursue Premarket Submissions - January 31st, 2023

The White House’s recent announcement that the Biden Administration plans to end the public health emergency on May 11th, 2023.

In a statement released on January 31st, 2023, the FDA indicates that manufacturers with Emergency Use Authorizations (EUAs) should consider the premarket submission process in order to stay on the U.S. market. The agency stated:

“Manufacturers are encouraged to pursue premarket submissions through the appropriate regulatory pathway (for example, 510(k), De Novo request, PMA) during the public health emergency so that devices authorized under an EUA can remain on the market after the EUA is no longer in effect” (read more).

While the public health emergency (319 PHE declaration) is ending, EUAs may still be granted (under section 564 declarations), but it is a good time to move towards traditional market pathways (510k, De Novo, PMA). If you will seek full FDA pre-market authorization and need any assistance with the application process, our team at CSSi LifeSciences is here to help. Simply reach out to us for support.

We understand that these changes can be overwhelming and want to ensure that you have all the information you need to make informed decisions. The FDA has provided a FAQ section with additional information, which you can access by clicking the link below:

 If you have any questions, please don’t hesitate to reach out to Damian Daszynski at ddaszynski@cssilifesciences.com. We are here to help.

FDA Town Hall Meeting – May 4, 2022

Below are the key points discussed during the town hall meeting with the Agency regarding COVID test kits.

  1. The SARS-CoV-2 reference panel for LoD is not available at this time.
  2. 510(k) vs EUA
    1. No premarket authorizations have been granted; therefore, the first submission will be a de novo.  Once the de novo is cleared, product code established, and special controls written, all future submissions will be 510(k).
    2. Prior to submission of the premarket authorization, submit a presubmission including:
      1. Planned testing.
      2. Usability and label comprehension proposed testing.
      3. Proposal on plans to use testing from EUA for the 510(k) submission.
      4. OTC clinical data from EUA can be used to support 510(k) for both OTC and POC.
      5. If planning to leverage the analytical and clinical data used to support the EUA for the 510(k), need to fully explain how all data collected.  Of importance in the clinical will be the comparator used.  For analytical testing, multiple lots need to be tested.  Again, this information should be provided in the presubmission package.
    3. No separate CLIA waiver is needed if OTC or POC was authorized under EUA.
  3. Timeline for conversion from EUA to full authorization
    1. Unlike the public health emergency that needs to be renewed every 3 months, the EUA declaration remains in effect until terminated by the HHS secretary.  The declaration is independent of the public health emergency.
    2. Companies are encouraged to move forward with plans for full clearance and should submit presubmission to the Agency.
    3. The question was asked if the transition from EUA to full authorization will occur in July.
      1. There is no end date for the EUA at this time.  Any closing dates being discussed are simply based on speculation and rumor.
      2.  The draft transition guidance needs to be finalized and published before the transition process can begin.
      3. Cannot predict when the final guidance will publish.
      4. The Agency will allow a transition period to allow products to stay on the market during the transition period.
      5. No transition date has been announced.  The final guidance will outline the timeline.
      6. The Agency is accepting EUA applications.  However, the Agency again reiterated that companies should proceed with submitting pre-subs for full authorization.
  4. Data from current prospective clinical studies show large rates of low viral loads with omicron, in the range of 30-40%, resulting in lower performance by the OTC kits.  In the past the low viral load rate was 10-20%.  If the clinical study is completed and the low viral load is >20%, may be able to recalculate performance.  Submit all data and apply new analysis.  ( No details were provided on the new analysis.  Perhaps look at low viral load performance separately.)  If the clinical study has not started, submit a plan for analysis to discuss how data will be analyzed if high percentage of low positive.
  5. For those companies interested in multiplex COVID and Flu testing
    1. Only prospective, freshly collected clinical samples can be used for the performance study.  The only exception they would consider is samples frozen in saline, however, they do not believe these samples exist.
    2. Flu A is present in the US; Flu B is not.  For Flu B, consider going to the southern hemisphere to get samples.
    3. Flu is not considered pandemic, only COVID, so the focus should be on COVID.  If sufficient samples have been obtained for COVID and not the flu, submit the results to the Agency and if authorized, mask the flu aspect of the test when released until sufficient flu data is available.
  6. Kit Manufacturing
    1. There are limited QMS requirements at this time, but the Agency plans to expand the requirements.
  7. Timeline to review EUA and PEUA
    1. The Agency continues to be challenged by the number of EUA and PEUA submissions.  EUA take priority over PEUA. If weeks have passed without a response, send email to templates.  Reviewer assigned should provide regular updates.
  8. Q-Sub
    1. Not accepting all pre submissions at this time, with the exception being for COVID.
    2. The goal is to review all Q-subs, but not there yet, as COVID Q-subs take priority.  Therefore, the timing for other Q-subs is extended.
    3. The Agency prefers to respond to Q-subs via email.  Meetings take a long time and are reserved for those when email will not suffice.  This is due to resource limitations at the Agency.
FDA Town Hall Meeting – April 20, 2022

Below are the key points discussed during the town hall meeting with the Agency regarding COVID test kits.

  1. FDA is seeing a slow upswing in the prevalence of COVID-19, at approximately 5% in the US.  Therefore, the Agency does not see issues in obtaining positive samples from patients for either POC or OTC clinical performance testing.  Only freshly collected samples can be used, no frozen samples.
  2. Agency is receiving 130/month PEUA and EUAs. They recently hired more staff and hope to reduce the expert review time for the EUA to 10 days.  Submissions will be prioritized based on submission data and production capabilities.  If questions are sent to the sponsor after the expert review, the Agency wants a response ASAP.
  3. Expiration dating – Up to 6 months will be allowed based on accelerated tested.  Real time data is needed to extend the self-life beyond 6 months.
  4. FDA prefers the OTC kits to have as few steps as possible.  They prefer OTC with pre-filled tubes.  They have seen usability issues when the lay user needed to add the diluent or buffer to the collection tube.  They have reports of people using the diluent as eye drops and dexterity issues adding the liquid.
  5. Any non-COVID IVD submissions will have a longer review time.
  6. Although the Agency requires a minimum of 500,000 kits/week be produced within 3 months of authorization, their expectations are for a much higher production capability.
  7. For the POC kits, they are noticing some kits are not performing as well when symptoms have been present for 7 days versus 5 days.
  8. For POC tests, the site should be able to perform high volumes of testing easily.
  9. High sensitivity RT-PCR comparator – Agency said to confirm acceptance of the proposed test prior to starting the clinical study.  They would not confirm what the cut off was to be considered high sensitivity.  Stated they would confirm in PEUA.
  10. Must report the Ct for the RT-PCR samples.
  11. The GMP requirements for the CMO are more than previously needed.  The authorization letter will detail the GMP requirements for the product.  They stated if the CMO is experienced with manufacturing IVD kits, the GMP requirements should not be an issue.  If changing CMO or location of the CMO, submit update to the FDA.
  12. On the call this week, unlike prior weeks, the FDA agents answered most questions referring participants to the guidance.

FDA Submissions

There are several ways to submit a product to the FDA for premarket approval. Two of the most well-known methods are the 510(k) premarket notification and the PMA premarket approval. The less frequently used De Novo submission is another option. These submissions result in a decision from the FDA that grants marketing authorization, either through clearance [510(k)], approval [PMA], or De Novo clearance [De Novo]. Additionally, there are other forms of premarket submissions to the FDA, such as Pre-submissions, IDE (Investigational Device Exemptions), HDE (Humanitarian Device Exemptions), and Master Files. The most popular submissions are explained in further detail below.

510(K) Submissions

To legally sell a Class I, II, or III device intended for human use in the US, a Premarket Approval (PMA) is not always necessary. In these cases, the manufacturer must submit a 510(k) to the FDA unless the product is exempt from the requirements specified in the Federal Food, Drug, and Cosmetic Act and doesn’t exceed the exemptions listed in sections .9 of the device classification regulation chapters (e.g. 21 CFR 862.9, 21 CFR 864.9). The 510(k) is a premarket submission to the FDA that aims to demonstrate that the device is at least as safe and effective as a device that is already legally sold and not subject to PMA. The manufacturer must compare their device to similar products already on the market and provide evidence to support their claims of substantial equivalency. Marketing of the device cannot commence until the FDA gives the go-ahead, which is signified by an order declaring the device as substantially equivalent (SE). Once the device is deemed SE, it can then be sold in the US.


The Premarket Approval (PMA) process is a thorough scientific and regulatory review conducted by the FDA to assess the safety and effectiveness of Class III medical devices. These devices, which are deemed to have the highest level of risk, are crucial for supporting or maintaining human life, preventing health impairment, or posing a potential risk of injury or illness. Given the level of danger associated with Class III devices, the FDA determines that general and special controls are not enough to ensure their safety and effectiveness. Thus, these products must go through the PMA application process outlined in section 515 of the FD&C Act before they can be marketed. It’s worth noting that some Class III preamendment devices may require a Class III 510(k). PMA submissions typically contain technical sections, including non-clinical laboratory studies and clinical investigations, and an inspection of the facility is often required to ensure compliance with 21 CFR 820 prior to approval.

De Novo

The De Novo pathway provides a solution for marketing novel, low- to moderate-risk devices that lack a recognized predicate device. Upon the successful evaluation of a De Novo submission, the FDA will create a classification for the device, establish necessary regulations, and determine the special controls necessary for future premarket submissions of similar devices. Companies with low- to moderate-risk novel devices have two options when considering the De Novo pathway. They can either submit a 510(k) to the FDA and, if they receive a “Not Substantially Equivalent” determination, request a De Novo review, or they can skip the 510(k) submission and proceed directly with a De Novo request. Devices that go through the De Novo process can be marketed and serve as predicates for future 510(k) submissions.

Pre-Submission (Pre-Subs)

The Pre-submission process to the FDA serves as a means for obtaining feedback and guidance on a device before its formal submission for marketing clearance. This process can be utilized for a variety of reasons, including meeting requests, assessing risk, addressing submission-related issues, and seeking answers to specific questions pertaining to a future submission or study protocol. The Pre-Sub Program, previously referred to as the Pre-IDE Program, offers sponsors the opportunity to receive input from the FDA before submitting an IDE or marketing application. It also provides a channel for the Agency to offer guidance on the development of protocols for non-significant risk (NSR) device studies or those conducted outside of the U.S. to support future marketing efforts. The Pre-Sub program therefore represents an effective path to market while also supporting the FDA’s mission of promoting new medical device innovations.

For any questions or support needs, please contact
Damian Daszynski at ddaszynski@cssilifesciences.com