FDA 510(k) Consulting

We provide guidance for your 510(k) submission, ensuring you have all the information needed and to answer all questions you may have.  We have worked directly with FDA branch chiefs and reviewers, which translates into extensive product knowledge and industry experience passed on to you throughout your 510(k) submission review.

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Guidance for Building a FDA 510(k) Submission

FDA clearance is vital to your market success. Our Bio-Med Consultants have over 15 years of experience in making sure your 510(k) submission is accurate and complete. Missing information and deficiencies in your 510(k) submission can lead to delays your product launch by months.

 

What is the 510 (k) process?

The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. The FDA does not "approve" medical devices; they "clear" them for sale. Once a FDA 510(k) number has been granted, it does not expire. However, you must remain in compliance with all FDA regulations to continue selling your product in the US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820.

Once you have submitted your 510(k), the FDA has 90 days to review it. Please note that review does not mean clearance. During the review process, they likely will ask you for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of your answer to their questions. If your product is cleared, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices – and you may therefore begin to market your device subject to the general controls provisions of the Food, Drug and Cosmetics Act."

Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is cleared for sale in the US.

Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the online FURLS system on the FDA website.

Please contact us if you would like to speak to one of our consultants.