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US FDA 510 K
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Expert advice, Preliminary predicative device analysis, Product Code and Regulation number identification, 510k preparation, Testing, US Agent service, Q-Submission, FDA review response, and 510k update.
FDA 510 K for Medical Devices
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 is a Predicate Device?
The term “Predicate Device” means an FDA 510K / 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 note Predicate device must be single unit preferable and presently available in the USA market without any product recalls in the past years.
One stop destination for Guidance, 510 k Preparation, Review, Medical Device Testing, US Agent Service, Answering to FDA review comments and file updation till clearance.
What is Substantial Equivalence?
510k requires a demonstration of Substantial Equivalence (SE) to a legally U.S. marketed device of similar intended use. SE means that the 510k applied device is at least 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 US FDA 510 k
No matter the device class or 510k type! We can solve every obstacle in the path of 510k Pre market Notification.
Abbreviated FDA 510 k
Abbreviated 510k is appropriate when the FDA guidance exists for specific medical devices, special controls are available for the demonstration of compliance and any voluntary FDA recognized Consensus Standards are available.
It must include the main elements of the Traditional 510k with the summary report on the use of the FDA guidance documents and/or special controls or declaration of conformity to the FDA recognized standards with the data that supports.
Traditional 510k
Traditional 510k is the original submission which 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 FDA 510 k cleared device.
FDA generally takes 90 days for the traditional 510 k Submission.
Special 510k
Special 510(k) is the submission in which already FDA cleared medical device has some changes which don’t require the FDA review of complete documentation, but only the summary.
These changes include design changes, labeling changes to the existing device including a certain indications of use. But those changes should not affect the safety and the performance of the device and well- established methods to evaluate the changes.
Every 510k files are scrutinized by FDA reviewers for substantial equivalence determination.
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Majority of the Class 1 device manufactures can sell in US soon after FDA registration and Listing with FDA.
510 k decision can be taken after identification of Device FDA Code and Regulation Number
Find the predicative device manufactures, Registration & Device Listing from FDA database
We control the documentation until FDA 510k Clearance. We never allow the customer to create or modify the files until FDA 510 k Clearance. We take your inputs only!!
How FDA 510 k Submission process?
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
How to prepare and submit FDA 510 k?
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.
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What next after FDA 510 k Clearance?
- Medical Device Establishment Registration
- Device Listing
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