Medical Device Establishment Registration & Listing for Class 1 and 510k cleared devices.
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Expert advice, Predicative device analysis, Product Code along Regulation number identification, 510(k) preparation, Identification of testing requirement and standard, US Agent service, Q-Submission, FDA review response, and update covered in our services.
FDA 510k Clearance
FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is 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 US FDA 510(k) if Pre-market Approval (PMA) is not required.
Most of the class I devices 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.
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What are Predicate Devices?
The term “Predicate Device” means a 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 single unit preferable and presently available in the USA market without any product recalls in the past years.
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What is Substantial Equivalence?
It a must to demonstrate Substantial Equivalence (SE) to a legally US marketed device of similar intended use. Meeting Substantial Equivalence to 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 effectivenes
Types of 510k's
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Special 510(k) submission is for already 510k cleared device has some changes which don’t require the full review, but only the summary documentation.
These changes include indications of use, design and labelling, 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.
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 FDA guidances 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 510 k documents
- For the Abbreviated clearance, locate the FDA Special Controls and/or voluntary consensus standards, if any
- Prepare the contents of the selected 510(k) in the specific FDA format
- Make it to the e-copy for submission
- Submit the user fee
Inhouse US Agent for "Q" Submission and final submission and inhouse experts for Interaction with FDA reviewer
FDA 510k and I3CGLOBAL!!
One among the largest regulatory outsourcing company 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 510k clearance on time.
Our service offerings are not just by verbal or email communication, we develop the complete 510k file on behalf of the client and take the whole responsibility till 510k clearance.
Medical Device FDA Registration and Listing for Class I devices and devices with 510k number. World most economic consulting Service.
Cost and Timeline
Medical Device Regulatory consulting professionals dedicated for European and USA FDA Regulations. Having in this field for more than 20+ years made us to know various type of devices and multiple tasks involved in each device.
Our economic and fixed pricing that suits to large and small manufactures with an added benefit of assured service makes us the top service provider for FDA Certifications and Clearances.
Frequently Asked Questions
What you mean by proposed predicative device? Is it necessary to include in 510k ?
Yes, it is necessary to submit to FDA, as substantial equivalence of the proposed device with a legally marketed device decides the 510(k) clearance. It is a critical part of 510k , you should include a comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalency.
What you mean by e-copy cover letter? Is it part of 510k pre-submission?
Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510k Submission?
We do have the PDF version of acceptance checklist for traditional as well as abbreviated. It can be used internally to ensure all the sections are included in the documentation during submission.
Do you have a ready to edit and use template for 510k summary?
*Attached the 510(k)-summary template.
What do you mean by Truthful and Accurate Statement? Is it a part of 510k File?
*We do have a ready to edit copy and the template is attached.
Is Summary and Certification a part of 510k File? Is it applicable for all devices?
*Template is prepared and attached in the folder
What is Declaration of Conformity? Is it part of FDA 510k?
Declaration of conformity is suitable section for both traditional and the abbreviated 510(k) submissions.
Explain the 510k requirement for the Biocompatibility. What is expected by a reviewer?
The reviewer will need information regarding detailed testing protocol and report. The protocol shall include the details of study title and standard, the test article preparation, detailed test method- positive and negative controls, test parameters and acceptance criteria, analysis of results. The report shall include the analysis of test result, conclusions made from the test result, device photograph etc.
Is Sterilization validation mandatory for 510k?
FDA released two guidance for the Sterility Information in Premarket Notification 510(k) Submissions for Devices Labelled as Sterile and Reprocessed Single Use Medical Devices.
Is Shelf-Life studies part of FDA 510k Documentation?
What you mean by Indication of Use? Intended use? explain both in details.
Indications of use defines the reasons or conditions under which the device would be used. The details of the disease or condition which can be diagnosed, prevented, cured or mitigated by the use of the device along with the patient population for which the device is intended comes under indications for use.
What type of Animal Testing is required to be a part of FDA 510k documentation?
What type of Clinical Information is part of FDA 510k submission?
What is the purpose of Financial Certification or Disclosure Statement in 510k Documentation?
It should be as part of the fda 510(k) , if the section does not apply then include the statement as “This section does not apply” or “N/A” under that heading.
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant.
What is the difference between Executive Summary and FDA 510k summary?
More details visit our blog section.
*Template available for purchase.