Some of the applicants will do pre-submission to FDA to avoid any undue surprise rejection in the last stage. 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 510k submission.

1. 510(k) SUBMISSION
STAGES

2. STAGES OVERVIEW
2
7
6
5
4
3
Identification Testing Initialsubmission 510(k) clearance
Additionalinformation
request
Initialdetails Documentation
2
1

3. STAGE 1- IDENTIFICATION
▰ Classify the medical device and check if it
requires 510(k)
▰ Identify the product code and regulation
number
▰ Complete establishment registration and
device listing
3

4. STAGE 2- INITIAL DETAILS
▰ Finalize Indications for Use
▰ Select predicate device to establish
substantial equivalence
▰ Identify clinical and non-clinical tests required
4

5. STAGE 3- TESTING
Initiate testing as per applicable standards
▰ Biocompatibility testing to demonstrate safety
▰ Performance testing to prove effectiveness
▰ Clinical testing (if required)
5

6. STAGE 4- DOCUMENTATION
▰ Prepare 510(k) file. For more details refer
https://www.fda.gov/medical-devices/premarket-
notification-510k/content-510k
▰ Include supporting information like device
drawing, manufacturing flowchart, test
protocols and reports, labelling etc.
6

7. STAGE 5- SUBMISSION TO FDA
▰ Pay 510(k) review fee
▰ Submission of 510(k) file for substantive
review
7

8. STAGE 6- ADDITIONAL INFORMATION
▰ FDA may request additional information (AI)
after review by day 60.
AI response includes:
▰ Justification for questions raised by FDA
▰ Corrections made as per FDA suggestions
8

9. STAGE 7- 510(K) CLEARANCE
▰ If substantial equivalence established, 510(k)
clearance is granted by FDA
9

10. THANK YOU
Presented by Neenu Jacob(Mrs)
Sr. Consultant
www.i3cglobal.com
e n q u i r y @ i 3 c g l o b a l . c o m
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