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510k Submission Flowchart

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510k submission

510k Submission Process

The 510k submission is the second most common pathway for marketing a medical device in the United States. It demonstrates that the device is substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. A 510k Submission document preparation including device testing, and clinical data consolidation takes up almost 4 to 5 months. Post submissions to the FDA generally take up to 6 months, for closing the review queries.


Our 510k consultants’ careful plan, strategic decisions, and expertise will ensure the early acceptance of the 510k file without RTA or AI and the successful 510k clearance of the submission. All applicants must submit a soft copy on CD and an e-copy. All foreign manufacturers are requested to have a US Agent for FDA correspondence officially.


Note: The service of the US Agent is different from the US Agent service for Establishment Registration.

FDA 510(k) Submission

Pre and Q 510k Submission

Pre or Q 510k Submission are the two types of submissions that allow the manufacturer/applicant to request formal feedback on files specific to (a) Test Protocols, (b) Substantial Equivalence, (c) Missing Sections, etc.


It allows the manufacturer/applicant to request formal feedback on the files of your medical device, specifically on (a) test protocols (b) substantial equivalence, (c) missing sections, etc. before you make a review payment and submit an application.

Would you like us to send an email with important information about 510(k) service within the next 2 minutes?

Benefits of Pre 510k Submission

Although Pre-Submission / Q 510k submission is not mandatory, we often recommend customers do so to gain an FDA view of the documents and if you have specific questions to the FDA to clarify. The consultants use this provision to seek valuable feedback on various topics, such as costly bench and animal testing, and clinical trials.


  • Better clarity on subject device requirements
  • Improved quality of final 510k file,
  • Enhanced transparency of the review process,
  • Smooth and clear review comments,
  • Potentially shorter total review times,
  • No fee

We offer the best guidance and solutions for 510k submission to worldwide manufacturers and specification developers. Our services are time-bound and economical. We match prices. So partner with us and experience the difference firsthand.

510k Submission Timeline

The duration of the 510k submission process and timeline can vary significantly depending on factors such as the complexity of the device, the completeness of the submission, and any interactions required with the FDA. Generally, the Food and Drug Administration aims to complete the review process within 90 days of acceptance, but actual timelines may be longer in the majority of the cases of applicants.







Select the Device and models
for US FDA 510k approval


20 Days


Identify Predicate Device with the same
indication and technology



If NOT substantially equivalent, follow the PMA route or, if substantially equivalent, follow the 510k route



Appoint I3CGLOBAL as Technical Consultants
and US Agent




Identify Device Code and Regulation Number along with verification of  Predicate Device, indication & technology.


90 Days


Identify the device Class and guidance document



Biological evaluation and test requirement identification in line with the predicate device

I 3 C


Samples send to the Laboratory



Evaluation of equivalent device compilation



Drafting of 510k file in line with available FDA guidance document.



Review of Risk analysis, Equivalent device data, Biocompatibility Test/Safety  test protocols



Review of Labels, User Manual/IFU, Shelf-life records/lifetime calculation, and pre-clinical study evidence



Pre 510k submission




Compilation  of 510k file by incorporating the pre-submission comments


90 Days


Compilation  of Pre-clinical and Biocompatibility and Safety testing



Compilation and release of the final draft

I 3 C






US Agent Appointment


20 Days


Review payment



eSTAR submission of file to FDA



Receipt of acknowledgement



Wait for the review comments


90 Days



Modify the 510(k) and provide additional supporting documentary evidence as per FDA review comments


60 Days




10 Days


Wait for the review comments or FDA 510k clearance letter


90 Days

Frequently Asked Questions

What is pre-sub checklist and pre-sub acceptance checklist? Provide a ready to edit and use template?

Pre-sub acceptance checklist: FDA staff will conduct an acceptance review using the Acceptance Checklist within 15 days after the 510k submission. The submitter will receive a notification regarding whether the submission has been accepted for review. The acceptance checklist can be internally used to check our documentation; it is unnecessary to have the template as it is being done by FDA staff.


The pre-submission checklist was the part of guidance “Requests for Feedback on Medical Device Submissions” issued on September 29, 2017. But it is superseded by “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”, issued on January 6, 2021. Currently no requirement for the pre-submission checklist.

Do you have ready to use Q-sub cover letter template?

You must submit an eCopy of your Q-Sub under section 745(A)(b) of the FD&C Act. An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or flash drive. Use the eCopy Validation Module to ensures your eCopy is formatted correctly. You must attach a paper copy of your company cover letter (including a signature) to the eCopy (CD, DVD, or flash drive).


A medical device submission package should be sent to the CDRH Document Control Center (DCC) at the following address:


U.S. Food and Drug Administration

Center for Devices and Radiological Health, Document Control Center (DCC) – WO66-G609, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002



  • ~ Enhanced process review
  • ~ Confirmation of Issues
  • ~ No Fee
  • ~ Smooth pathway provider for selection of submission type
  • ~ Clarity regarding each aspect of submission and marketing
  • ~ Detailed understanding for appropriate 510k submission
  • ~ Pre-defined meeting

What is Performance testing and Bench testing? How could help in faster 510k clearance

Performance data should be provided to help demonstrate the SE of your device to predicate the device. The data may include test results from engineering, bench, design verification, human factors, animal testing, and clinical studies and clinical trials. Tests should be conducted on all sizes and models of the device.


FDA classifies non-clinical performance testing under bench testing. These tests are performed by either a device manufacturer or a third-party testing facility (e.g., test laboratory), which includes all bench testing and will depend on the specifics of the actual device or device type. Non-clinical bench performance testing includes tests to evaluate mechanical and biological engineering performance (e.g., fatigue, wear, tensile strength, compression, etc).


The reviewer will require test report summaries, test protocols, and test reports. The test report summary ideally includes a brief description and summary of the various tests performed as part of bench testing. The complete test reports also should be included as part of the premarket submission. Test protocols contain the testing methods, test objective, acceptance criteria, and data analysis plan. The contents of the test protocol can also be included as part of the test report and submitted as a single document.

How long the Q submission process? Can I apply multiple times?

You must submit an eCopy of your Q-Sub under section 745(A)(b) of the FD&C Act. An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or flash drive. Use the eCopy Validation Module to ensure your eCopy is formatted correctly. you must attach a paper copy of your company cover letter (including a signature) to the eCopy (CD, DVD, or flash drive).


Timeline:  75-90 days (*21 days for urgent public health issues)


Day 1                  Review Team

Day 5                 Acknowledgement

Day 15               Acceptance Review

Day 30 – 40     Meetings Scheduled if needed

Day 70              FDA Feedback

Day 75              Meeting

Day 90             Meeting Minutes from Submitter

Day 120            FDA revisions to the meeting, if needed


If FDA determines that the information provided is insufficient, the request will be refused to accept, or RTA and the sponsor should provide the additional information, which will be logged in as an amendment to the Q-Sub.


No, when it is a single device, one should not apply multiple times.