FDA 510(k) Consultants

For over 20 years, Empirical Technologies Corp. has been providing valuable expertise into various aspects of regulatory compliance. With a long-standing relationship with the FDA and a track record of success in submission clearance, we’re proud to assist clients as they navigate the 510(k) submission process.

As FDA 510(k) consultants, some of the services we provide include evaluating your medical device’s classification, performing GAP analysis, and collecting the necessary data and documentation to complete the 510(k), among others. We aim to remove the stress and burden of 510(k) submission from your shoulders by bringing skill and dedication to the partnership, so you can enjoy a more seamless experience with desirable outcomes at the end of the submission process.

510(k) Submission Process

The Food and Drug Administration (FDA) is responsible for ensuring that all cosmetics, food, pharmaceuticals, and medical devices meet specific standards and are safe for American consumers. The 510(k) is a Premarket Notification of a medical device submitted to the FDA and reviewed by their Center for Devices and Radiological Health. There are a number of different levels of review that will occur once a 510(k) has been submitted, but a thoughtful, thorough document will receive far more expedient consideration and approval than one which is placed on RTA Hold or requires additional information.

Empirical Technologies Corp. is proud to have assisted with more than 200 successful 510(k) submissions, so we know how to properly complete submissions to meet the precise specifications of the FDA. Though the average amount of review days required to receive FDA clearance hovers around 177, the average review days for 510(k) forms submitted by Empirical is just 131. Our record of success has not been achieved by sheer luck—we’ve worked hard to set ourselves apart and redefine industry standards.

Why Empirical Technologies Corp?

The Empirical team has decades of experience working to achieve FDA clearance; in fact, our staff members have more than 40 years of combined regulatory and consulting expertise, which is part of the reason we are 20% to 30% faster than the industry average when it comes to obtaining FDA clearance.

In addition to a long-standing relationship with the FDA, Empirical can also provide support from a thoroughly-trained staff. Each member of our team is RAPS trained and/or certified (RAC), so you can trust that we are well-versed in even the most finite aspects of 510(k) submission. When you invest in 510(k) consulting from Empirical, you will receive a level of expertise far beyond the industry norm.

Perhaps the most convincing reason to work with Empirical is simply the fact that we have a 100% success rate in FDA submission clearance. There’s no reason to struggle with the technical, involved process of submitting your 510(k) to the FDA on your own; Empirical Technologies Corp. understands what it takes to gain success on this front, and we’re willing to apply our skills to help you.

Contact us today to learn more about how Empirical’s FDA 510(k) consultants can help you with submission.