Quality documentation along with technical guidance for traditional & abbreviated types.
We act as US FDA agent for establishment registrations and correspondence.
Medical Device Establishment Registration and Listing for Class 1 and FDA cleared device.
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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.
FDA 510k - An 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 devices in the United States intended for human use must submit a 510(k) 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 file drafting, e-copy conversion, and submission through the US Agent service. Few manufacturers opt for Q submission before final submission.
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Role of I3CGlobal FDA 510k Consultants
As a prominent FDA consultant 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 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+ 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 files on behalf of our clients and take full responsibility until the FDA 510k clearance is obtained.
Consultants with a strong combination of scientific, technical, and regulatory knowledge, as well as excellent documentation and FDA response skills, can significantly contribute to obtaining 510(k) approval faster and more efficiently
Predicate Device FDA 510k
The term Predicate Device refers to a FDA 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.
Substantial Equivalence Definition
It is a must to demonstrate substantial equivalence to a legally US-marketed device with 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 are not limited to
- Intended use,
- Design,
- Safety,
- Adherence to standards,
- Labelling,
- Biological Compatibility,
- Performance characteristics,
- Materials used in the construction/ chemical composition,
- Manufacturing Methods,
Every file is scrutinized by FDA reviewers for substantial equivalence determination. You need fast support to reach clearance. That’s where we come in. To know more, check out details to see how our services fit your business! For any questions, contact us.
FDA 510k Clearance Process For Medical Device
FDA 510k clearance depends on three types—traditional, abbreviated, and special and are respective ways to prepare the file. Once the legal submitter chooses the type, there is specific guidance available for that type. Among the three, tradition 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 FDA 510k documentation is not a form,” but it shall include all the information required as per 21 CFR 807.87. It includes the steps 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 in the specific format.
- Make it to the e-copy for submission.
- Submit the user fee.
Different Types of Medical Device 510(k)
Traditional 510k is an original submission that normally has to be provided for the medical device, that requires 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 FDA 510k submission.
Abbreviated 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, as well as a brief report on the usage of FDA guidance documents and FDA-approved standards.
Special 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.
With over 24 years of expertise in the 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 FDA 510k clearance for worldwide customers. Read More about our economic pricing or contact us for more details
Difference between Clearance, Approval and Granted
The language used by the Food and Drug Administration (FDA) often varies depending on the associated risk levels of the products they regulate. Generally, the FDA employs different terminology and regulatory requirements for products based on their risk levels, to ensure appropriate oversight and consumer protection
Clearance: When a medical device has undergone a 510(k) submission, which the FDA has reviewed and provided 510(k) clearance
Approval: For Class III medical devices rigorous review and successful submission of a premarket approval (PMA), the device is given Approval
Granted: Medical devices using the De Novo pathway must be Granted by the FDA before they can be legally marketed in the United States.
Frequently Asked Questions
What’s the difference between a 510K vs PMA?
510(k) clearance is indeed the authorization from the FDA to market a medium-risk device. This pathway is used for devices substantially equivalent to a legally marketed predicate device. On the other hand, Premarket Approval (PMA) is required for high-risk and novel medical devices, typically those without a substantially equivalent predicate.
What are exemptions to the 510k requirements?
- Preamendment devices or devices legally marketed in the U.S. before May 28, 1976
- Class II devices with special controls
- Class II devices with published performance standards
- Certain class II devices with Premarket Notification exemption
- Most of the class I devices (referred under section 513)
How to identify the right Product Code and Regulation Number of Medical Device?
How long does it take for the FDA to review a 510k file?
FDA aims to complete the file review within 90 days, but the actual timeline can often extend beyond this. The duration of the review process can vary based on factors such as the complexity of the device, the quality of the submission, and the need for additional information or clarification from the medical device company. The back-and-forth communication between the FDA and the applicant can take up to nine months.
How to proceed if my device is innovative?
If you have an innovative technology or a novel device, it may not fit into an existing regulatory classification and a product code. In such cases, it’s advisable to seek guidance from the FDA to determine the appropriate risk classification and regulatory pathway.
For the manufacturers of innovative low-risk devices that don’t have an appropriate predicate device for a 510(k) submission, the De Novo classification process can be pursued.
What are common reasons for rejections?
- Failure to establish substantial equivalence
- Inadequate test data
- Deficiencies in clinical data
- Labelling not in compliance
- Incomplete documentation and supporting evidence