On March 24, 2020, in response to the insufficient supply of FDA-cleared ventilators for use in healthcare settings to treat patients during the Covid-19 pandemic, the Department of Health and Human Services (HHS) announced Emergency Use Authorization. Pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act), the EUA authorized the emergency usage of ventilators and the modification of devices such as anesthesia gas machines, positive pressure breathing devices to be used as ventilators or ventilator tubes.
This has opened up the possibility of other essential medical devices and products reaching the market faster through the EUA route, especially in emergency situations such as the pandemic.
But for that, the products must conform to the criteria for safety, performance, and labeling set forth in Section II and Appendix of the act. Based on the webinar ‘FDA’s Response to Covid-19: The FDA’s Use of Emergency Authorizations’ by Judith Meritz, Partner, Meritz & Muenz LLP, we provide you a EUA roadmap to ensure timely and proper submission of forms for this process.
The Guidelines
Section II of Appendix A provides manufacturers and stakeholders with the opportunity to submit their products to be added to the EUA under the listed products in Appendix B. The EUA addresses two types of products:
- Products that are not currently marketed in the US and have not received a 510k or a PMA
- Devices that are currently marketed in the US but were modified and require the manufacturer to submit a new premarket notification (510(k)) to FDA as stated in FDA’s Enforcement Policy
Getting Your Device Added to the EUA List
For a business to get its ventilator, ventilator tubing connector, or accessory to be added to Appendix B, which lists all the approved products, it will have to fill and submit an Interactive Review Template for Emergency Ventilators. This form seeks information on:
- Who the applicant is and the key contact
- Regulatory information such as is the marketing authorization outside of the US and if the products have the necessary certification to market in different countries
- State how it fulfills the unmet need and justifies why the product needs to be given EUA
- The label, IFU – Instructions for Use, Facts Sheet, how to use information accompanying the product are also important for EUA
- Applicable standards, compliance, documentation to support contract manufacturing if it is outsourced and so on
- Criteria for Safety, Performance, and Labeling (Appendix A) and how it conforms
- Device description including the specifications and drawings
- Facility requirements needed for the product to be usable in the hospital or the healthcare facility
- Benefit/risk assessment, which is very important for the FDA
The template was designed to capture the data/information needed by the FDA to support the inclusion of the product under the Emergency Ventilator EUA and Appendix A. Therefore, the FDA requires the forms to be complete as incomplete forms are returned and not considered.
The EUA Process
The process for getting EUA to have your product listed in Appendix B include:
- Submitting information using the interactive review template, as mentioned above.
- On submission, you will receive a PEAU number and an acknowledgment letter. All subsequent correspondence should have that number in the subject line as otherwise FDA will either return it or it will be lost forever. A point to remember is that the FDA has limited resources and lots of applications. So, to get noticed, make sure you make a compelling case.
- FDA will also assign a reviewer for your application and share the contact number. If none has been assigned to you, make sure you follow up and initiate an interaction. The onus of getting the review done lies on you as the reviewers are already overworked.
- There could be additional requests for information that requires a response with specific technical data. Respond in a timely manner to keep your application live. Any delay can cause it to be ignored or declined.
- Once the process is complete, you will get a concurrence letter informing you of the addition of your ventilator to Appendix B. Or, hold your heart, it could be a declination letter
Waivers
Given the emergency situation and the great demand for ventilators and related products for patient welfare, FDA has waived some of the requirements applicable in the pre-Covid-19 world. For instance, FDA has waived documentation for the following:
- Current good manufacturing practice (CGMP) requirements, including the quality system requirements under 21 CFR Part 820 governing the design, manufacture, packaging, labeling, storage, and distribution of the authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B that are used in accordance with this EUA; and
- Registration and listing requirements, including the requirements under 21 CFR Part 807.
FDA’s focus for EUA authorization is primarily with regard to benefits and risks of the modifications being made to the product and assessing if they are fit for the purpose.
For a detailed video on the subject,
ComplianceQuest to Manage Your EUA Application Process
The role of a robust quality management system becomes especially important during times of change. As device manufacturers seek to get the EUA approval, they will need to submit proof of compliance to applicable regulatory standards, the risks associated with their products, and the benefits. They will have to assess how a modification of their product to be used as a ventilator will impact patient safety and help. They will also have to provide sufficient documentation.
In these difficult times with limited staff at our disposal, EUA poses several challenges. ComplianceQuest’s Quality Management Software with its change management, compliance, and document management system in addition to automated regulatory submissions can empower device manufacturers to ensure compliance to the new requirements to increase their chances of approval and their product being added to the list of approved products in Appendix B.
To find out more, request to speak to one of our experts here:
http://www.compliancequest.com/contact-us