Getting an expedited 510(k) submission
So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?
Well, if FDA requires a 510(k) to clear the product for marketing in the United States, that is your next step – preparing a 510(k) submission that meets all requirements and successfully passes FDA or third-party review.
The regulatory submission process
The regulatory submission process can seem daunting, especially for someone who is unfamiliar with regulatory requirements.
That’s where we come in. Our experts at Medical Devices and Pharma will work with you to get the necessary reports, technical data, and other information to compile and write an effective 510(k) and submit it electronically to the Food and Drug Administration (FDA).
First, let’s get acquainted
The first step in the process is to sign a non-disclosure agreement (NDA) to ensure that we maintain all aspects of our business relationship in the strictest of confidence. We will then meet with you and your team and get to know each other as we discuss your company, product, and goals. Since we will be working together, building those working relationships is important to us.
After our discussion, we will send you a checklist of submission inputs, so we can gauge how well your new or redesigned product is ready for the regulatory phase. If it is not quite ready for prime time, we can identify potential gaps and help you resolve them.
Scope the project
If your project documentation is ready or nearly so, we will offer a quote for services based on a flat rate and a guaranteed completion date. That means that you will not be charged for costs of individual resources with varying levels of participation; our team will be completely dedicated to your project.
FDA submission
After you have paid the FDA MDUFA fee for the submission, we will submit your 510(k) electronically to the agency. We will be in contact with the reviewer throughout the process and will inform you if there are any requests for additional information or other issues that arise.
And we will notify you the minute we receive notification of the 510(k) clearance.
My product is cleared for the U.S. market, now what?
There are a few other activities you will need to do before you can sell your product here. Chief among them are to register your establishment and generate a product listing on FDA’s FURLS system. But do not worry – if this is all new to you, we can help. We offer a turn-key solution to companies that are new to the U.S. regulatory requirements and structure.
More information
Do you have a new product or redesigned product that requires a 510(k)? Just fill out this form and we will be in touch! We look forward to exceeding your expectations.