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We solve every obstacle in the path of Class I, II, and III Medical Device 510 k Premarket Notification

FDA 510k

510k Documentation

Quality Documentation along with technical guidance for traditional and abbreviated FDA 510k.

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We act as US Agents for establishment registrations &Ā  510k correspondence.

Registration Service

Medical Device Establishment Registration & Listing for Class 1 and 510k cleared devices.

One-Stop Solution for US FDA 510k

Expert advice,Ā  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 updateĀ  covered in our services.

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Medical Devices
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 ā€˜kā€™ number.

Why Choose I3CGlobal for FDA 510k Certification?

We are one among the best, largest and most economic Regulatory Compliance Solution Provider for Medical Device Pre Market Notification / 510k

Registration & Listing Search

Find the predicative device manufactures, Registration & Device Listing from FDA database

Device Classification Database Search

510 k decision can be taken after identification of Device Code and Regulation Number

Establishment Regisatrtion

Majority of the Class 1 device manufactures can market in USA soon after FDA registration and Listing.

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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 EquivalenceĀ  to applied device proves the deviceĀ  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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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.

Abbreviated FDA 510 k

Abbreviated 510k 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 510k with the summary report on the use of the FDA guidance documents and DOC to the FDA recognized standards with the data that supports.

Special 510k

Special 510(k) submission is for already 510k cleared device has some changes which donā€™t require the fullĀ  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.

Every 510k files are scrutinized by FDA reviewers for substantial equivalence determination.

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FDA 510k Clearance 1

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USFDA
510k 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 ā€œformā€ 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

Why Choose I3CGlobal for FDA 510k?

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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Medical Device FDA Registration and Listing for Class I devices and devices with 510k number. World most economic consulting Service.

510k Certification
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.

 

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