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Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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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.
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:
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:
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 process for getting EUA to have your product listed in Appendix B include:
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:
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,
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:https://www.compliancequest.com/contact-us
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