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    510k Submission Process and File requirements

    510k Submission & Process

    If you’re new to the medical device 510k Submission process, you’re in the right place! The various steps involved in the process and types of submissions are set out here. 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.

     

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

     

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

    FDA 510k Pre-Submission (Q-Submission)

    Pre-Submission or Q-Submission allows the manufacturer/applicant to request formal feedback on 510k files specific to (a) Test Protocols, (b) Substantial Equivalence, (c) Missing Section, etc.

     

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

    Benefits of 510k Pre Submission

    • 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

    Know what to be included in the 510k file!!

    Given below 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 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

    Understand the stages

     

    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

    510k 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 FDA 510k clearance letter

    CLIENT

    90 Days

    510k Submission and Duration

     

    fda 510k consultants

    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 the 15 days after the submission. The submitter will receive notification regarding whether the submission has been accepted for review. The acceptance checklist can be internally used to check our documentation, there is no necessary to have the template as it is being done by FDA staff.

     

    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 of 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 a flash drive. Use 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

     

    Advantages:

    • 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, and 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 a flash drive. Use 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).

     

    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 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.