We are a bunch of regulatory consultants backing FDA 510k Clearance & Submissions.
We solve every obstacle in the path of Class I, II, and III Medical Device FDA 510k Premarket Notification.
Quality Documentation along with technical guidance for traditional and abbreviated 510k.
We act as US FDA Agents for establishment registrations & correspondence.
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.
Find the predicative device manufactures, Registration & Device Listing from FDA database
510k decision can be taken after identification of Device Code and Regulation Number
Majority of the Class 1 device manufactures can market in USA soon after FDA registration and Listing.
Find how much budget for 510k medical device clearance & approval process!
Types of FDA 510k's
Good Decision Making reach your goal faster
Traditional 510k
It is an original submission that normally has to be provided by the medical devices which require the FDA clearance by 510k submission according to the regulation 21 CFR 807.
It can also be used to submit if there is any change in the previous 510k cleared device.
It generally takes 90 days for the traditional 510k Submission.
Abbreviated 510k
This submission is appropriate when the FDA guidance exists for specific medical devices for the demonstration of compliance and any voluntary FDA recognized Consensus Standards are available.
It must include the main elements of the Traditional 510(k) with the summary report on the use of the FDA guidance documents and DOC to the FDA recognized standards with the data that supports.
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.
Depending on the three types of FDA 510k i.e., traditional, abbreviated, and special, there are respective ways to prepare the 510(k). Once the legal submitter chooses the type, there are specific guidance available for the type of 510(k). Among the three, traditional is the 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 (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 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 the regulation 21 CFR 807.87. It includes the steps as given below:
- Find a predicate device (legally marketing 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 510(k) 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, manufacturing process, effectiveness, labeling, 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
The term “Predicate Device” means a 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 to the device in question.
It is important to know Predicate Device must be a single unit preferable and presently 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 made us know various types of devices and multiple tasks involved in each device. Our economic and fixed pricing that suits large and small manufactures with an added benefit of assured service makes us the top service provider for 510k Certification and Clearances.
- FDA 510k Process
-
Depending on the three types of FDA 510k i.e., traditional, abbreviated, and special, there are respective ways to prepare the 510(k). Once the legal submitter chooses the type, there are specific guidance available for the type of 510(k). Among the three, traditional is the 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 (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 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 the regulation 21 CFR 807.87. It includes the steps as given below:
- Find a predicate device (legally marketing 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 510(k) 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, manufacturing process, effectiveness, labeling, 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?
-
The term “Predicate Device” means a 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 to the device in question.
It is important to know Predicate Device must be a single unit preferable and presently available in the USA market without any product recalls in the past years.
- Certificate Cost and Timeline
-
Medical Device Regulatory professionals dedicated to European and USA FDA Regulations. Having been in this field for more than 20+ years made us know various types of devices and multiple tasks involved in each device. Our economic and fixed pricing that suits large and small manufactures with an added benefit of assured service makes us the top service provider for 510k Certification and Clearances.
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.