Follow Us:

US FDA

Home FDA 510k Submission
Quick Contact

    Still not found?

    510(k) Submission Process and File requirements

    510k submission process chart
    510k submission process

    FDA 510k Submission

    If you are new to medical device FDA 510k submission process, you are at the right place! The various steps involved in the process and types of submissions are listed here.

     

    Careful planning, strategic decisions and expertise of our consultants will ensure the early acceptance of the 510(k) file without RTA or AI and the successful clearance of the 510(k) submission.

     

    All applicants must submit  soft copy in CD and e-copy. All foreign manufactures are requested to official have US Agent for FDA correspondence. ( Note: The service of US Agent is different from US Agent service for Establishment Registration).

    US FDA 510k Submission Consultants

    FDA 510k Pre-Submission (Q-Submission)

    Pre-Submission or Q-Submission allows the manufacturer / Applicant to request formal feedback on your medical device 510k files specifically on (a) Test Protocols, (b) Substantial Equivalence, (c) missing section etc.

     

    Pre-Submission or Q-Submission allows the manufacturer / Applicant to request formal feedback on your medical device 510k files, specifically on (a) test protocols (b) substantial equivalence, (c) missing section etc., before you make FDA review payment and submit the 510(k) application.

    Benefits of Pre-Submission

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

    Consultants and US Agents for FDA 510k Submission

    FDA reviewers may scrutinize your 510k submission multiple times until all the supporting evidence submitted comply. Nothing works more effectively when weighed against an experienced consulting company for the timely completion and submission of the FDA 510k. We support by:

    • Finding out the FDA regulation and device code.
    • Double confirming if the classification is correct.
    • Determining who will be the owner and official correspondent for the 510k submission process.
    • Confirming predicate device(s) that is close to the device in question.
    • Appointing US Agent for foreign manufacturers and specification developers.
    • Paying close attention to the formatting of the submission.

    FDA 510k Submission Contents

    The information required for the contents of 510k includes different sections as below:

    • Medical Device User Fee Cover Sheet (FDA -3601)
    • CDRH Pre-market Review Submission Cover Sheet
    • 510k Cover letter
    • Indication for Use statement
    • 510k Summary
    • Truthful and Accuracy Statement (FDA template)
    • Class III Summary and Certification
    • Financial Certification or Disclosure Statement
    • Declarations of Conformity and Summary Reports
    • Executive Summary
    • Device Description
    • Substantial Equivalence Discussion
    • Proposed Labeling
    • Sterilization and Shelf-life
    • Biocompatibility
    • Software
    • Electromagnetic Compatibility and Electrical Safety
    • Performance Testing – Bench
    • Performance Testing – Animal
    • Performance Testing – Clinical

    Given above are the basic contents of the 510k file which has to be followed in the 510k submission process. The device-specific documents and changes describing documents with the evidence can also be submitted in the Special 510k.

    FDA 510k Submission Process & Clearance

    PHASE I

    Stages

    Activity

    Responsibility

    Timeline

    1

    Select the Medical Device and models
    for USFDA approval

    CLIENT

    20 Days

    2

    Identify Predicate Device with same
    indication and technology

    CLIENT + I 3 C

    3

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

    CLIENT + I 3 C

    4

    Appoint I3CGLOBAL as Technical Consultants
    and US Agent for clearance

    CLIENT

    PHASE II

    5

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

    I 3 C

    90 Days

    6

    Identify the device Class and guidance document

    I 3 C

    7

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

    I 3 C

    8

    Samples send to Laboratory

    CLIENT

    9

    Evaluation of equivalent device compilation

    I 3 C

    10

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

    I 3 C

    11

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

    CLIENT + I 3 C

    12

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

    CLIENT + I 3 C

    13

    Pre-submission

    CLIENT + I 3 C

    PHASE III

    14

    Compilation  by incorporating the pre-submission comments

    I 3 C

    90 Days

    15

    Compilation  of Pre-clinical and Biocompatibility/Safety testing

    I 3 C

    16

    Compilation and release the Final Draft

    I 3 C

    17

    Review

    I 3 C

    PHASE  IV

    18

    US Agent Appointment

    CLIENT

    20 Days

    19

    Review payment

    CLIENT

    20

    Submission in Hard copy and E-Copy

    I 3 C

    21

    Receipt of acknowledgment

    CLIENT

    22

    Wait for the review comments

    CLIENT

    90 Days

    PHASE V

    23

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

    CLIENT + I 3 C

    60 Days

    24

    Re-submission

    I 3 C

    10 Days

    25

    Wait for the review comments or 510k clearance letter

    CLIENT

    90 Days

    Generally, the FDA 510k process (file preparation and submission) and device testing take up almost 4-5 months. Post submission, the FDA generally takes up to 3-10 months including the closing of the review queries.

    Looking for more information about the FDA 510k Pre-submission and original submission, process, or clearance, please write to enquiry@i3cglobal.com. Our team will understand your device and advise you on how to make the move!

    Post Market Surveillance (SOP & Templates)