Role of FDA 510k Consultant

in providing Guidance, 510k Preparation, Submission and FDA Communication.

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

Step 1:

Identify the device regulation number and device code.

Step 2:

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

Step 3:

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

Step 4:

FDA 510k Preparation, along with preclinical 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 the FDA (on behalf of the 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 the USA.

Benefits of using service from MedDeviceCorp for FDA 510(k)

  • Our FDA 510k technical consultants' previous experiences help to improve the quality of 510k documents and thereby reduce the review and communication time.
  • 26+ full-time regulatory consultants. Separate consultants involved in the development of individual modules/annex.
  • MedDeviceCorp - One stop solution for a. Consulting, b. Testing, c. US Agent.
  • Payments based on deliverables (Stage wise payment). Payment option in INR, USD and EUR.
  • Offices in Germany, India & the USA. The average 510K preparation timeline is 90 days.
  • Experience counts more than anything!

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

Additional Resources for 510k