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FDA 510k Clearance
FDA 510 k 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 510 k 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 510 k 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.
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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.
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