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How a professional consultancy can help you getting FDA approval for 510K?

  • Which medical products require a 510k technical file for FDA registration?
  • What are the steps to prepare a file for 510k submission?
  • How long does a 510k file remain valid for?

If these are your questions, don’t worry, today we bring you the complete solution.

May be you have been thinking a lot

One of the first steps in selling a Class 2 or IVD medical product in the USA is to submit a Pre-Market Notice, known as FDA 510k to the FDA. Technically, the FDA does not approve medical products or IVDs for sale upon presentation of the 510k, but rather grants a clearance to be sold in the USA.

Who should submit the pre-market 510k notice?

Manufacturers wishing to introduce class 2 medical products or IVDs must submit their 510k file to the FDA. 510k is also required when the manufacturer changes the purpose of using the product, or when a product already released for sale has its technology changed in a way that may impact its safety or effectiveness. Hiring a professional consultancy for your FDA 510k submission is easy and fast.

The two significant methods

In order for the FDA 510k process to be successful, a two-step method is used.

Step 1: Previous analysis and evaluation

The purpose of use and the design of the product will allow determine the "Product Code" and "Regulation Number". The consultancy will then evaluate similar products that have already had FDA approved 510k submission, to determine if these products are substantially equivalent to your product. Then provide a list of documents and information specific to your product, which will be necessary for the preparation and submission of the 510k.

A consultant will then be appointed to review the information provided by the client and determine whether they are suitable for submission. After evaluating this documentation, a detailed report will be prepared which will describe what information is still missing or incomplete, and which is necessary for the submission of 510k to be successful.

Step 2: Compile 510k File and FDA Submission

When all information and documents are received, the consultancy will prepare the submission of your 510k. They will prepare the technical comparison of your product with the predicate product.

They will also prepare all 21 sections of your application and submit a physical and electronic copy of your 510k to the respective CDRH division of the FDA. The agency will coordinate the payment of 510k submission fees. After that the consultancy will promptly report all information received from the FDA regarding your submission.


About This Author


Biologics Consulting GroupBiologics Consulting Group
full service regulatory & product development consulting
Joined: February 4th, 2020
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