Medical Device Establishment Registration & Listing for Class 1 and 510k cleared devices.
What is 510k?
FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device are at least as safe and effective, similar to that of the legally marketed device that is not subjected to PMA. Organizations planning to launch Class I, Class II, and Class III medical devices in the United States intended for human use must submit 510k if Pre-market Approval (PMA) is not required.
Most of the class I medical device are exempt from 510k requirements. During the review of the 510k file, if the FDA finds the device as Substantially Equivalent (SE), the FDA will give the clearance with a ‘(k)’ number. We provide expert advice, predictive device analysis, product code along with regulation number identification, preparation, Identification of testing requirement and standard, US Agent service, Q-Submission, FDA review response, and update covered in our services.
Why Choose I3CGLOBAL for FDA 510k Certification?
85% Success Rate, 180 Plus 510k Clearance, 112 Plus manufactures, Serving manufacturers and specification developers from 1999, We are one among the best, largest and most economic regulatory compliance solution provider for medical device 510(k) premarket notification.
Types of FDA 510k's
Good Decision Making reach your goal faster
This submission is for already cleared device has some changes which don’t require the full review, but only the summary document.
These changes include indications of use, design, and labeling, but also those changes should not affect the safety and the performance of the new modified device and well-established methods to evaluate the changes.
Every FDA 510k files are scrutinized by FDA reviewers for substantial equivalence determination.
You need support to reach 510k clearance fast. That’s where we come in. To know more check this video how our FDA 510k services fit for you business! For any question contact us.
One of the largest regulatory outsourcing companies in the world packed with the best performing and qualified subject expert team. No matter how big or small the manufacturer is, but someone with good device knowledge joins hands with our team, we assure the rest with clearance on time. Our service offerings are not just by verbal or email communication, we develop the complete FDA 510k file on behalf of the client and take the whole responsibility till the 510(k) clearance.