Role of 510k Consultants

in providing Guidance, 510k Prepration, Submission and FDA Communication

The following are the major steps involved in the preparation and submission of FDA 510(k)

Step 1:

Identify device regulation number and device code.

Step 2:

Discuss and debate with client to identify the predicate /equivalent 510k cleread device.

Step 3:

Identify 510k type a. Traditional 510(k) b. Abbreviated FDA 510(k) c. Special FDA 510(k).

Step 4:

510k Prepration along with pre clinical studies and External testing.

Step 5:

510k Pre-submission to FDA.

Step 6:

510k updation as per FDA review comments.

Step 7:

US Agent appointment and FDA review Fee payment.

Step 8:

US FDA 510(k) submission ( Hard copy & E copy).

Step 9:

Communicate and follow up with FDA (on behalf of client).

Step 10:

FDA 510k modification and resubmission as per FDA review comment.

Step 11:

Wait for additional review comments if any till receipt of 510k number.

Step 12:

Establishment Registration with 510k number and list the 510k cleared device.

Step 13:

Initiate sales and marketing the device in USA.

Benefits of using service from I 3 CONSULTING for 510k:

  • Previous experiences of our 510k technical consultants helps to improves the quality of 510k documents and thereby reduce the review and comminucation time.
  • 26+ full time regulatory consultants. Separate consultants involved in the development of individual modules/annex.
  • I 3 CONSULTING - One stop solution for a. Consulting, b. Testing, c. US Agent.
  • Payments based on deliverables (Stage wise payment). Payment option in INR, USD & EUR.
  • Offices in Germany, India & USA. Average 510K preparation timline is 90 days.
  • Experience counts more than anything!!! We have...

Looking for more information please contacts us. Our experts will be in touch with you from the nearest location.

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