Medical Device Establishment Registration and Listing for Class 1 and FDA 510k cleared device.
What is FDA 510k?
FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III device in the United States intended for human use must submit a 510k if pre-market approval is not required.
Most class 1 devices are exempt from 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number.
We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with 510k drafting, e-copy conversion, and 510(k) submission through US FDA Agent service. Few manufacturers opt for Q- 510k submission before final submission.
Why Choose us for FDA 510k Clearance?
As a prominent FDA 510k clearance consultants on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely 510k clearance irrespective of the manufacturer’s size or the regulatory knowledge of their internal team.
With an impressive 85% success rate, a track record of over 350+ FDA 510k clearances worldwide, and a history of serving more than 150+ manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.
Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete 510k file on behalf of our clients and take full responsibility until the FDA 510k clearance is obtained.
Predicate Device FDA 510k
The term Predicate Device refers to an 510k or PMA cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.
It is a must to demonstrate substantial equivalence to a legally US-marketed device with a similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but not limited to’
- Intended use,
- Adherence to standards,
- Biological Compatibility,
- Performance characteristics,
- Materials used in the construction/ chemical composition,
- Manufacturing Methods,
Substantial Equivalence Scrutiny
Every 510k file is scrutinized by FDA reviewers for substantial equivalence determination. You need fast support to reach 510k clearance. That’s where we come in. To know more, check out details to see how our services fit for your business! For any questions, contact us.
FDA 510k Submission Fees
With over 24 years of expertise in medical device domain, our seasoned regulatory professionals offer fixed, economical pricing tailored for large, medium and small manufacturers and specification developers. Our assured service path makes I3CGLOBAL, the best choice for 510k clearance for worldwide customers. Read More about 510(k) Fees>>
FDA 510k Clearance Process For Medical Device
FDA 510k clearance depending on the three types—traditional, abbreviated, and special 510k—there are respective ways to prepare the file. Once the legal submitter chooses the type, there is specific guidance available for that type of 510k.
Among the three, traditional is the most basic and can be followed under any circumstances. In all types, the submitter must prove the substantial equivalence of the subject device with the legally marketed, FDA-cleared device (the predicate device).
This includes a comparison of the intended use, technological, performance, biological, mechanical, and electrical characteristics of the devices. If there are differences in any of the characteristics, it must be proved that those differences will not affect the safety and performance of the device, and it must propose scientific methods to evaluate the same with the performance data.
The 510k documentation is not a form,” but it shall include all the information required as per 21 CFR 807.87. It includes the steps as given below:
- Find a suitable device (legally market an FDA-cleared device).
- Locate the FDA guidance document to prepare the documents.
- For the abbreviated clearance, locate the special controls and/or voluntary consensus standards, if any.
- Prepare the contents of the selected 510k in the specific format.
- Make it to the e-copy for submission.
- Submit the user fee.
Types of FDA 510k's
Good Decisions will reach your goal faster
This 510k submission is for an already cleared device with some changes that don’t require the full review but only the summary document.
These changes include indications of use, design, and labelling, but they should not affect the safety or performance of the new, modified device, and well-established methods can be used to evaluate the changes.