FDA 510(k) Submission Process
If you’re new to the medical device FDA 510(k) 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 510(k) Submission process (file preparation and submissions) and device testing take up almost 4-5 months. Post submission, the FDA generally takes up to 3-10 months, including closing the review queries.
Our consultants’ careful planning, strategic decisions, and expertise 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 a soft copy in CD and e-copy. All foreign manufacturers are requested to have US Agent for FDA correspondence officially.
(Note: The service of US Agent is different from US Agent service for Establishment Registration).
FDA 510(k) Pre & Q Submission
Pre or Q Submission allows the manufacturer/applicant to request formal feedback on FDA 510(k) 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 510(k) 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 510(k) application.
Benefits of FDA 510(k) Pre Submission
- Better clarity on subject device requirements
- Improved quality of final 510(k) file,
- Enhanced transparency of the review process,
- Smooth and clear review comments,
- Potentially shorter total review times,
- No fee
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 510(k) 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 510(k) 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 of 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 |
510(k) Submission in Hard copy and E-Copy |
I 3 C |
||
|
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 + I 3 C |
60 Days |
|
24 |
Re-submission |
I 3 C |
10 Days | |
|
25 |
Wait for the review comments or FDA 510(k) clearance letter |
CLIENT |
90 Days | |
Know what to be included in the 510k file!!
510(k) Submission Process Timeline & Duration
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 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; 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 510(k) submission
- ~ Pre-defined meeting
What is Performance testing and Bench testing? How could help in faster 510(k) 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 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).
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.