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510k Submission Flowchart

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510k submission

FDA 510k Submission

The 510k Submission and medical device testing takes up almost 4-5 months. Post submissions generally take up to 3-10 months, including 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 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

510k Q or Pre-Submission

Q-Sub; or Pre-Sub; are the two types of 510k 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.

510k Q-Submission Benefits

Although Pre-Submission / Q-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

510k Submissions and Review Timeline

The duration of the 510k submission 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.

PHASE I

Stages

Activity

Responsibility

Timeline

1

Select the Medical Device and models
for US FDA approval

CLIENT

20 Days

2

Identify Predicate Device with the same
indication and technology

CLIENT + I3C

3

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

CLIENT + I3C

4

Appoint I3CGLOBAL as Technical Consultants
and US Agent

CLIENT

PHASE II

5

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

 I3C

90 Days

6

Identify the device Class and guidance document

 I3C

7

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

I 3 C

8

Samples send to the Laboratory

CLIENT

9

Evaluation of equivalent device compilation

 I3C

10

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

 I3C

11

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

CLIENT + I3C

12

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

CLIENT + I3C

13

Pre-submission

CLIENT + I3C

PHASE III

14

Compilation  by incorporating the pre-submission comments

 I3C

90 Days

15

Compilation  of Pre-clinical and Biocompatibility/Safety testing

 I3C

16

Compilation and release of the Final Draft

I 3 C

17

Review

 I3C

PHASE  IV

18

US Agent Appointment

CLIENT

20 Days

19

Review payment

CLIENT

20

Submission in Hard copy and E-Copy

 I3C

21

Receipt of acknowledgement

CLIENT

22

Wait for the review comments

CLIENT

90 Days

PHASE V

23

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

CLIENT + I3C

60 Days

24

Re-submission

 I3C

10 Days

25

Wait for the review comments or FDA 510k clearance letter

CLIENT

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

 

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, 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.