Follow Us:

We are a Bunch of Regulatory Professionals & Experts in FDA 510k Submission(s)

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

FDA 510k

510k Documentation

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

US Agent Service

We act as US Agents for establishment registrations &  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,  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.

Technical Team

One among the largest pool of talented team in the world.

Document Control

ISO 27001:2013 Certified data security system. NDA with team members.

Cloud Documentation

No matter where you are . Spot files updated in your system

Medical Devices
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.

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.

510K Quote Request Form

Find how much budget for device 510k clearance

85% Success Rate, 180 Plus 510k clearances, 112 Plus manufactures, Serving manufacturers and specification developers from 1999,

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.

 

Read more about Predicate Device >>

One stop destination for FDA 510k.
Guidance, Preparation, Medical Device Testing, US Agent Service,
Answering to FDA comments and 510k file updation.

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

Good Decision Making reach your goal faster

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 510k cleared device.

 

FDA generally takes 90 days for the traditional 510k Submission.

Abbreviated FDA 510k

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 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.

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

You need support to reach FDA 510k Clearance fast . That’s where we come in.

Discover how our services fit for you

US FDA
510k Process

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

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.

 

Read more about I3CGLOBAL Team Role >>>

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.

 

Understand how much will cost for a 510k >>

Know more about our special Fees for Covid emergency Devices >>

Frequently Asked Questions

What you mean by proposed predicative device? Is it necessary to include in 510k ?

The predicate device is a legally marketed, 510k cleared device used to determine substantial equivalence of the proposed/new device for 510k Submission is called proposed predicate device.

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?

You are not required to include an electronic version of your company cover letter on the eCopy.  This is because FDA date-stamps and scans in the paper copy of your company cover letter and places it in the official record. But, as explained above, you must attach a paper copy of your company cover letter (including a signature) to the eCopy (CD, DVD, or flash drive). You have to resubmit a company cover letter with every replacement of eCopy.

Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510k Submission?

Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated, or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each question for the elements identified as RTA (Refuse to Accept) items.

 

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?

Yes. The parameters and the sections may vary based on the device requirements.

*Attached the 510(k)-summary template.

What do you mean by Truthful and Accurate Statement? Is it a part of 510k File?

Truthful and Accurate Statement must be a part of all 510(k) submission. In this section the submitter give statement that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

 

*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?

The summary and certification is applicable for only class III devices which is not called for PMA submission, and it should be a part of 510(k) documentation.  The Class III Summary is a summary of the problems associated with the device’s safety and effectiveness. It shall contain the whole summary of information regarding the device and other legally marketed device and the citation of such data if applicable. For class II and Class I devices this section is not applicable and can include the statement as “This section does not apply” or “N/A” under that heading.

 

*Template is prepared and attached in the folder

What is Declaration of Conformity? Is it part of FDA 510k?

Declaration of conformity is to provide information relating to the use of voluntary consensus standards, including any declarations of conformity or the basis of general use of such standards for the traditional submissions. Whereas for abbreviated 510(k) submissions to provide the information regarding the use of standards, or a summary report that describes how the device complies with the special controls associated with the particular device type or that is recommended in any relevant device-specific guidance.

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?

FDA recommends the evaluation of biocompatibility of tissue contacting materials, if the medical device contains components that come into direct or indirect contact with tissue. Biocompatibility testing is performed as per the standard ISO 10993-1. The biocompatibility studies shall perform even if the material and construction of subject device and predicate device are same, to prove the biological safety of the device.

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?

Sterilization validation is required for only sterile medical devices. The section for sterility can be not applicable for non-sterile medical devices.

 

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?

Shelf-life studies are part of FDA 510k documentation. If you are claiming any shelf-life period to your device, then the necessary studies and reports shall keep in the submission. Usually FDA prefers Real-time stability studies, even if the accelerated studies are accepting. FDA required the performance test also conduct after the real-Time/accelerated study to prove the safety and effectiveness. If the device is supplied sterile then its recommended to perform the sterilization and the packaging validations after the shelf-life period.

What you mean by Indication of Use? Intended use? explain both in details.

Intended use define the purpose of your device. It indicates what your device is meant to do as per the claims being made on the labelling.

 

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?

The animal studies utilized for the assessment of the devices initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. More information visit our blog section.

What type of Clinical Information is part of FDA 510k submission?

Clinical study is conducted to collect data to establish safety and effectiveness of investigational devices. Additional Information visit out blog section.

What is the purpose of Financial Certification or Disclosure Statement in 510k Documentation?

A Financial Certification or Disclosure Statement must include in 510(k).

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?

Executive summary and the 510(k) summaries are part FDA 510(k) requirements and is mandatory.

More details visit our blog section.

 

*Template available for purchase.