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510(k) Submission Process and File requirements

510k submission process chart
510k submission process

FDA 510k Submission

If you are new to the Medical device FDA 510k Submission process, below information will provide adequate knowledge in various steps involved in the complete cycle and types of submissions.

 

Careful planning, strategic decisions, well document alignment, and experience of Consultants will decide the faith of your 510k success and or early acceptance of file without any RTA.

 

All applicants must submit one hard copy, soft copy in CD and e-copy. All foreign manufactures are requested to official have US Agent for FDA correspondence. ( Note: The service of US Agent is different from US Agent service for Establishment Registration)

US FDA 510k Submission Consultants

FDA 510k Pre-Submission (Q-Submission)

Pre-Submission or Q-Submission allows the manufacturer / Applicant to request formal feedback on your medical device 510k files specifically on (a) Test Protocols (b) Substantial Equivalence, (c) missing section etc.

 

Before you make FDA review payment and submit original 510k. Pre-Submission always remove the risk and worry about the quality of the file especially in the quality of test protocols and reports.

Benefits of Pre-Submission

  • Improved quality of final 510k file,
  • Enhanced transparency of the review process,
  • Smooth and clear review comments,
  • Potentially shorter total review times,
  • No fee

Consultants and US Agents for FDA 510k Submission

FDA reviewers may scrutinize your 510k submission multiple times until all the supporting evidence submitted comply. Nothing works more effectively when weighed against an experienced consulting company for the timely completion and submission of the FDA 510k. We support by:

  • Finding out the FDA regulation and device code.
  • Double confirming if the classification is correct.
  • Determining who will be the owner and official correspondent for the 510k submission process.
  • Confirming predicate device(s) that is close to the device in question.
  • Appointing US Agent for foreign manufacturers and specification developers.
  • Paying close attention to the formatting of the submission.

FDA 510k Submission Contents

The information required for the contents of 510k includes different sections as below:

  • Medical Device User Fee Cover Sheet (FDA -3601)
  • CDRH Pre-market Review Submission Cover Sheet
  • 510k Cover letter
  • Indication for Use statement
  • 510k Summary
  • Truthful and Accuracy Statement (FDA template)
  • Class III Summary and Certification
  • Financial Certification or Disclosure Statement
  • Declarations of Conformity and Summary Reports
  • Executive Summary
  • Device Description
  • Substantial Equivalence Discussion
  • Proposed Labeling
  • Sterilization and Shelf-life
  • Biocompatibility
  • Software
  • Electromagnetic Compatibility and Electrical Safety
  • Performance Testing – Bench
  • Performance Testing – Animal
  • Performance Testing – Clinical

Given above are the basic contents of the 510k file which has to be followed in the 510k submission process. The device-specific documents and changes describing documents with the evidence can also be submitted in the Special 510k.

FDA 510k Submission Process & Clearance

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  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.

Looking for more information about the FDA 510k Pre-submission and original submission, process, or clearance, please write to enquiry@i3cglobal.com. Our team will understand your device and advise you on how to make the move!

Post Market Surveillance (SOP & Templates)