A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

Did you know that the FDA rejects more than 75% of 510(k) applicants?

Unfortunately, even the slightest delay or setback could spell disaster for your growing life sciences company. The sooner you get your product out there, the sooner you can go to market and start turning your cash flow in the right direction.

With a greater understanding of the FDA 510(k) processes and a few insider tips for the industry's leading experts, you can get to market quickly and increase your chances of becoming a life sciences success story.

An Overview of the FDA 510(k) Process (And How to Shorten It)

What is the FDA 510(k)? 510(k) is a premarket submission made to the FDA to demonstrate that your medical device is safe and effective. U.S. medical device companies are required by law to submit an FDA 510(k) application.

Here is a quick overview of the FDA 510(k) process and timeline.

1. Submit Your Application

Your application should be submitted online to CDRH or CBER's document control center. You can find out more about the electronic submission program and how to submit your digital application by visiting eCopy Program for Medical Device Submissions.

2. Acceptance Review

After you've submitted your application, the document control center will send it to the appropriate ODE or OIR Division for acceptance review. A lead reviewer is assigned to your application. Within 15 days, you should receive the lead reviewer's contact information, as well as the status of your application.

Those applications that are not accepted will be placed on an RTA hold. Applicants are given 180 days to address issues. Failure to do so may result in a withdraw.

3: Substantive Review

During the substantive review, the lead reviewer will contact you within 60 days of receiving your application via email or a phone call to let you know if you’re ready for the interactive review, or if they need more information from you to make a decision.

Step 4: Notification of Approval or Rejection

The last step, step four, is when the FDA sends you a decision letter to notify you of approval or rejection. This whole process should happen within 100 days, according to the FDA’s website.

Related Reading: 4 Reasons Overhauling the FDA 510(k) is a Great Move

How to Get Approved Faster

Getting FDA approval for your medical device might seem like a long and arduous process, but there some preparations you can do to make it go smoother and help speed things up.

Hire a Consultant

The red tape that the FDA requires you to go through is complex and takes time, knowledge, and skill to fully understand.

You should consider hiring an FDA consultant to help you navigate the FDA 510(k) application and approval process. A seasoned consultant should know the process inside and out and be able to guide you on exactly what to do to get approval.

The sooner you bring in a consultant, the better. They can even help you set up an eQMS (quality management system) to help you get FDA approval faster.

Before choosing a consultant to work with, check their reviews and verify their references. You can seek feedback from their former clients to do a deeper background check and make sure they know their field.

Are you not sure how to find and hire an FDA consultant? Let us help. Our experts have compiled a list of the 6 best medical device consultants to choose from.

Look for the Common Mistakes of Others

Spend some time researching the common pitfalls other companies have made when submitting their FDA 510(k) application so your company won't suffer a similar fate.

To help, we’ve compiled a list of the most common mistakes you should avoid:

Read through them carefully and bookmark this page so you can double-check your application before clicking submit.

  • Inadequate or Inconsistent Documentation
  • Failure to Use the FDA 510(k) Submission Checklist
  • Not Running all the Required Tests
  • Forgetting to Do Shelf Life Studies in Real-Time
  • Not Understanding the Risk Management Requirements
  • Incorrectly Formatting Your Submission
  • Inaccurate Device Descriptions
  • Discrepancies in Indications of Use
  • Not Performing Validation Testing

As you can see, it’s incredibly easy to make a careless mistake that leads to the FDA rejecting your application.

One of the most common mistakes we see is the first one on this list — not documenting the development of your product every step of the way. Inadequate documentation is the fastest way to get rejected.

Let us show you how Qualio can help you create and manage all the documents you need to have for the FDA to approve your device.

Get an eQMS that Makes Document Management Easy

Implementing an eQMS from the very start is the best thing you can do for your company. An eQMS helps you stay organized and document everything correctly from the beginning.

Failure to document your process can not only have your application rejected, but it can cause you to experience further delays because you aren't following FDA or international regulations.

Qualio is an eQMS that was created specifically for medical device manufacturers — so you can be sure that you're going to have everything you need to help you maintain compliance and get approved faster.

But, don't take our word for it. Compare Qualio with our top competitors and decide for yourself which eQMS platform is right for you.

Download our free guide with 12 Questions to Ask Before You Buy an eQMS. It will help you choose the right eQMS platform for your company.