Medical Device Establishment Registration & Listing for Class 1 and 510k cleared devices.
FDA 510k Certification For Medical Device
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 is not required.
Most of the class 1 medical devices are exempt from 510k requirements. During the review of the file, if the FDA finds the device as Substantially Equivalent, the FDA will give the 510k clearance with a ‘(k)’ number. We are FDA 510k Consultants and 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 Clearance?
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 FDA 510k premarket notification.
Types of FDA 510k's
Good Decision Making reach your goal faster
This 510k 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 FDA 510k clearance fast. That’s where we come in. To know more check this video how our 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 complete 510k file on behalf of the client and take the whole responsibility till the FDA 510k clearance.