Manufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get 510k?” is one of the most frequent inquiries that businesses ask.

However, the answer would have depended on various factors, but learning the process will help you skip unnecessarily long waits and speed the submission process. We help companies at I3CGlobal succeed on 510k submissions

The 510k Process: What is it?

The FDA mechanism that assures a medical device is the same as, or substantially equivalent to, a legally marketed device (predicate device) in the U.S. is the 510k. If they can show equivalence, the company is cleared to market the device.

The Effects of 510k Approval Time

As such, how long is 510k cleared? It depends on several factors:

• Type of Device:

The 510k process is usually followed by class I and class II medical devices but high-risk devices can take more time for approval.

• Quality of Submission:

Delay is the reality of submissions that lack information or documentation. A good submission goes through the process much faster.

• FDA Workload:

Each year the FDA reviews thousands of submissions, and a specific workload of a particular FDA office can impact how quickly a 510k submission will be reviewed.

• Additional FDA Requests:

The clock stops if the FDA wants more information during the review — and the length of time that is taken to respond can extend the overall approval time as well.

Average Time for 510k Approval

How long on average does one take 510k approval? In most cases, the FDA reviews a complete and accurate submission in 90 days. Yet, the 90 days specified above are not extended to any situations of requests for additional information and deficiencies in the application.

FDA data indicates that the average from submission to clearance is 3 to 6 months. This includes the original review and all return communication between the FDA and the company submitting.

I3CGlobal is Better 510k Submission Choice Why?

That doesn’t have to be though if you have the right partner to walk you through the FDA’s 510k process. I3CGlobal is a company that offers efficient preparation of and submission of a high quality 510k application in time to reduce delay and increase your chances of approval.

Our staff of experts have extensive knowledge with regulatory standards who will help in finishing the task.

Conclusion

The review period of an official FDA 510k submission is 90 days in length but can take another 3 to 6 months from the time a submission is filed due to the complexity of the submission, the quality of the filing, and any additional requests by the FDA.

If you partner with an experienced 510k submittal expert, like I3CGlobal, you can minimize delays and help guarantee a streamlined 510k submission in order to bring your medical device to the market faster.

To help you start your 510k process or seek guidance for your 510k submission, contact us at I3CGlobal and we’ll make sure that you make it through the FDA clearance route in a smooth and efficient manner.