Because of COVID-19, the FDA has launched its Emergency Use Authorization Guidance to help accelerate the process for inventors, engineers, and manufacturers like you to take part in combatting this devastating situation. And MethodSense is here to help.
First, using our extensive EUA submission experience working directly with the FDA, we have created the EUA Resource website to support those in our medical device community wanting to submit device authorization requests under this emergency Guidance. This resource combines our 20 years of compliance proficiency with numerous experts in the medical device field to answer your questions about the EUA Authorization process.
Then, once you’ve gained a better understanding of the EUA process, MethodSense can walk with you through the steps to FDA approval for your device. Whether you have an existing product that is currently FDA-approved for another purpose but could help fight the Coronavirus, or you are developing a new product, our purpose is to help you help others.
The EUA Resource includes:
- Secure login access for qualified requesters
- FAQs with answers from a pool of volunteer industry experts, including FDA staff
- Links to important informational site pages on FDA.GOV, HHS.GOV, AAMI.ORG, and others
- Downloadable documents, including FDA Guidance supporting the EUA, checklists, and other tools
- Are you a medical device company or a manufacturer of a new medical device interested in a EUA? Request access to the EUA Resource website by email. Please include your full name, company name, and email.
- Are you an industry expert wanting to join the pool of professionals volunteering as a Site Curator? Send an email with “Curator” in the subject line and include your name, company, areas of expertise, email, and phone number.
If you are interested in learning more about our EUA Resource in general, please contact us today. Let’s all be part of the solution—together.
The EUA Resource Site uses MethodSense’s proprietary Quality Management Software LuminLogic (www.luminlogic.com), a thin client, web-based, and highly configurable Software as a Service application intended to support regulated content. The application meets compliance and auditability requirements of 21 CFR Part 11. The quality management software and site is hosted in a professional and secure environment with backups in multiple locations as expected for a compliant application. Numerous client on-site inspections by FDA auditors assure that both the application and the hosted facility maintain the desired level of compliance.