510k submission

FDA 510k Submission & Clearance Process

If you are new to the process of FDA 510k submission and clearance, below information will provide adequate information in general with various steps involved in the complete cycle of 510k submission.

510k Submission process is divided into 5 phases:

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  substantially equivalent follow FDA 510k route

CLIENT + I 3 C

4

Appoint I 3 CONSULTING as Technical Consultants
and US Agent for FDA 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 FDA guidance document

I 3 C

7

Biological evaluation and test requirement Identification in line with 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 / life time calculation and preclinical study evidences

CLIENT + I 3 C

13

FDA Pre submission

CLIENT + I 3 C

 

PHASE III

14

510k  compilation  by incorporating the pre-submission comments

I 3 C

90 Days

15

Compilation  of Preclinical and Biocompatibility / Safety testing

I 3 C

16

Compilation of 510k and release the Final Draft

I 3 C

17

Review

I 3 C

 

PHASE  IV

18

US Agent Appointment

CLIENT

20 Days

19

FDA 510k review payment to FDA

CLIENT

20

FDA submission in Hard copy and E Copy

I 3 C

21

Receipt of acknowledgement from FDA

CLIENT

22

Wait for the review comments

CLIENT

90 Days

 

PHASE V

23

Modify the 510k and provide additional supporting documentary evidences as per FDA review comments

CLIENT + I 3 C

60 Days

24

Resubmission

I 3 C

10 Days

25

Wait for the review comments or 510k clearance letter

CLIENT

90 Days

Post 510k Submission & Clearance, I 3 CONSULTING will help manufacturers to complete establishment registration and device listing. The same will be updated in FDA website, followed by, device can be marked in United States of America.

Looking for more information about the FDA 510k process, submission or clearance, please write to enquiry@i3cglobal.com. Our team will understand more about your device

 

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