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The Ultimate Guide to hiring a professional FDA Emergency Use Authorization EUA and 510k Consultant

Our FDA Emergency Use Authorization EUA consultant is authorized to assist in emergency preparedness and response, including the development and delivery of new or unapproved medical products (drugs, biologics, and medical devices) for use in emergency situations. Thomas Regulatory Resolution 510k Consultants can help you navigate FDA regulatory requirements to bring your device to market.


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Thomas Regulatory

a year ago | 2 min read

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration authorized the emergency use of certain health products under certain circumstances. Our FDA Emergency Use Authorization EUA consultant is authorized to assist in emergency preparedness and response, including the development and delivery of new or unapproved medical products (drugs, biologics, and medical devices) for use in emergency situations.

The Thomas Regulatory Resolution Team supports EUA applications and strategies with a solid understanding of FDA requirements for EUA related to COVID-19; we continue to keep up with changing requirements as they evolve during this emergency due to the current global corona virus pandemic. From providing strategic roadmaps for navigating different EUAs for COVID-19 products to developing commercial use plans for products available under the EUA, the Regulatory Resolutions of Thomas can advise clients on how to achieve their specific short- and long-term goals to ensure they are in line with FDA requirements and guidelines.

How can we increase your odds of a successful FDA EUA submission?

To take advantage of medical device consulting companies, you should place them on the bottom tier of your assembly, as this will help you ensure that they know all the components of the equipment items you provide and can give you suitable advice give you the survivability and consistency you can face. Making sure you are ready to submit your EUA application is essential, otherwise, you will lose valuable time. The FDA is very sensitive to EUA submissions, but it certainly doesn't want to approve products under study, doesn't have time for lengthy exploratory conference calls, and FDA has no patience for requests for incomplete submission.

They want strong submissions for relatively mature products that have proven safety data and are in advanced efficacy testing. The Thomas Regulation Resolution FDA Emergency Use Authorization EUA consultant can help ensure that your application is ready for FDA review. In some cases, the FDA will ask you to participate in a pre-EUA submission to discuss specific items related to product testing and clinical expectations. Pre-EUA is the first step towards continuous interactive application leading to EUA. We can also help you through this process.

How does our 510k Consultant work?

Failure to follow FDA regulations can have costly consequences, so it's important to understand how to effectively communicate with them. Thomas Regulatory Resolution 510k Consultants can help you navigate FDA regulatory requirements to bring your device to market. The FDA 510k process is the means by which medical device manufacturers can demonstrate that their device is an equivalent device in terms of safety and effectiveness. If you're a manufacturer or spec developer and you have a new medical device that needs pre-market approval, you'll need to submit a 510k application.

We help customers prepare and submit 510,000 faster with less chance of receiving an initial “Reject Acceptance” (RTA) request or “Additional Information” (AI) request from the FDA. Our $510,000 consultant is a pre-marketing submission to the FDA to demonstrate that a marketed device is safe and effective, which is essentially equivalent to a device approved legally marketed (21 CFR 807.92(a) (3)) is not subject to prior marketing approval. Significant equivalence criteria are set forth in 21 CFR 807.87 and 807.81. We have an entire section at Thomas Regulatory Resolutions dedicated to assisting you in the FDA 510k approval process. Our 510k Consultants experts will help you determine if your product requires a 510k authorization and if so, they will guide you through the process.

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Thomas Regulatory

TRR is a consulting firm in the Quality, Quality Management Systems, Regulatory Affairs, Global Regulatory Submissions (including FDA medical device consultant) and Compliance (Audit Preparation, Audit Training, Audit Support, Internal Auditing) Space specializing in the medical device space, general manufacturing space, and life sciences space (Bio-medical and Bio-Pharma). TRR was founded on the principles of providing LEAN regulatory and quality and auditing support to the industry at a competitive rate in order to get client products to market quicker and get ISO certification quicker (ISO 9001 and ISO 13485).


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