510k Submission
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.
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!!
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 Â 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.
510k Submission and Duration