The document outlines the stages of a 510(k) submission for medical devices, which includes identification, initial details, testing, documentation, submission to the FDA, responding to additional information requests, and obtaining 510(k) clearance. Each stage involves specific tasks such as classifying the device, establishing substantial equivalence, conducting tests, and preparing necessary documentation. Successful completion of these stages leads to FDA clearance if substantial equivalence is demonstrated.

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
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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
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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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