FDA 510k Medical Device Clearance!
We are a bunch of regulatory professionals backing FDA 510k medical device clearance and approval. We solve every obstacle in the path of Class I, II, and III medical device 510(k) premarket notification.
Quality documentation along with technical guidance for traditional and abbreviated FDA 510ks.
We act as US FDA agents for establishment registrations and correspondence.
Medical Device Establishment Registration and Listing for Class 1 and 510k cleared devices
FDA 510k Overview
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 medical devices in the United States intended for human use must submit a 510k if pre-market approval is not required.
Most class 1 medical 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 510k clearance 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 FDA submission through US Agent service. Few manufacturers opt for Q-Submission before final submission.
Why Choose US for FDA 510k Clearance?
With an impressive 85% success rate, a track record of over 350 plus 510(k) clearances worldwide, and a history of serving more than 150 plus manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.
Find the predictive device manufacturers, registrations, and device listings from the FDA database.
A 510(k) decision can be taken after identification of the device code and regulation number.
Majority of the Class 1 device manufactures can market in USA soon after FDA registration and Listing.
Types of FDA 510k's
Good Decisions will reach your goal faster
Traditional FDA 510k
FDA 510k is an original submission that normally has to be provided by the medical devices that require FDA clearance according to 21 CFR 807.
It can also be used to submit if there is any change in the previously cleared device.
It generally takes 90 days for the traditional 510k submission.
Abbreviated FDA 510k
This 510k submission is appropriate when FDA guidance exists for specific medical devices for the demonstration of compliance and any voluntary FDA-recognized consensus standards are available.
It covers traditional 510k, as well as a brief report on the usage of FDA guidance documents and DOC to FDA approved standards, as well as supporting data.
Special FDA 510k
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.
Every FDA 510k file is 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 out this video to see how our services fit for your business! For any questions, contact us.
The term “predicate device” mean FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use (b) indications for use (c) similar technological characteristics as the device in question.
It is important to know the predictive device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.
Medical device regulatory professionals dedicated to European and USA FDA regulations. Having been in this field for more than 20 years, we know the various types of devices and the multiple tasks involved in each device. Our economic and fixed pricing that suits large and small manufacturers with the added benefit of assured service makes us the top service provider for 510k clearance.
Depending on the three types of 510k—traditional, abbreviated, and special—there are respective ways to prepare the file. Once the legal submitter chooses the type, there is specific guidance available for that type of 510(k). 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 510(k) 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.
It is a must to demonstrate substantial equivalence (SE) to a legally US-marketed device of similar intended use. Meeting substantial equivalence to the applied device proves the device is as safe and effective as the predicate device.
Following are the major criteria of Substantial Equivalence determination.
- SE is based on establishing intended use, design, safety, chemical composition, biocompatibility, performance, standards, materials, the manufacturing process, effectiveness, labelling, and other characteristics, as applicable.
- same intended use as the predicate
- same technological characteristics
- different technological characteristics and does not raise different questions of safety and effectiveness.
- What are Predicate Devices?
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The term “predicate device” mean FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use (b) indications for use (c) similar technological characteristics as the device in question.
It is important to know the predictive device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.
- Cost for 510k?
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Medical device regulatory professionals dedicated to European and USA FDA regulations. Having been in this field for more than 20 years, we know the various types of devices and the multiple tasks involved in each device. Our economic and fixed pricing that suits large and small manufacturers with the added benefit of assured service makes us the top service provider for 510k clearance.
- Explain 510k Process
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Depending on the three types of 510k—traditional, abbreviated, and special—there are respective ways to prepare the file. Once the legal submitter chooses the type, there is specific guidance available for that type of 510(k). 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 510(k) 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.
- What is Substantial Equivalence?
-
It is a must to demonstrate substantial equivalence (SE) to a legally US-marketed device of similar intended use. Meeting substantial equivalence to the applied device proves the device is as safe and effective as the predicate device.
Following are the major criteria of Substantial Equivalence determination.
- SE is based on establishing intended use, design, safety, chemical composition, biocompatibility, performance, standards, materials, the manufacturing process, effectiveness, labelling, and other characteristics, as applicable.
- same intended use as the predicate
- same technological characteristics
- different technological characteristics and does not raise different questions of safety and effectiveness.
As a prominent 510k consulting organisation 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. Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete FDA 510k file on behalf of our clients and take full responsibility until the 510k clearance is obtained.