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Jon Speer

FDA Compliance

Six Tips to Make Sure Your 510(k) Submission Is Accepted

Planning and organization will help you avoid the FDA’s refusal

Published: Tuesday, August 23, 2016 - 15:18

Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?

Then I spoke with a couple of other regulatory experts—one who consults with the FDA and another who is a former FDA reviewer—and each confirmed that the statistic sounds about right.

Prior to submitting a 510(k), I encourage you to spend some time thinking about the role the FDA plays in this process, the pressure a FDA reviewer has, and the ramifications if a mistake is made during the 510(k) review process. It’s possible that actual patients could be injured if a mistake is made. So, when your 510(k) gets kicked back to you because something is missing or a document is incorrect, realize why. 

The following six tips are simple to implement and will help ensure your 510(k) submission won’t be summarily rejected.

Create a plan

Preparing a 510(k) submission is a project all by itself. Expect to spend about 100 hours just putting together and writing the submission. A good plan can help with this, especially when you're coordinating with others as you compile the necessary documentation.

Fortunately, the required contents for your submission are already well-defined by the FDA in the 510(k) checklist.

As part of a good plan, review the 510(k) requirements with your team to ensure everyone agrees what is and is not applicable to your submission. Review the 510(k) requirements while they are  still in development, while documenting your user needs and design inputs. And do it early—before the 510(k) submission deadline imposed by your management is upon you.

Get organized early

If you know you’re going to submit a 510(k) for your device, there’s a huge advantage in starting the writing process in parallel with product development efforts. So much of the content of your design controls feeds into the contents of a 510(k).

One thing I like to do is create folders according to the particular 510(k) sections and share them with the project team. This is a great way to communicate what’s needed for the submission and to help foster collaboration. As documents and records are drafted pertaining to a particular section, place a copy in these folders, and number and name them according to the 510(k) checklist.

One drawback is ensuring your submission includes the latest and best information. Often documents and records are fluid and dynamic. Use a project management and document management discipline (and maybe a solid document management system) to assist.

Part of being organized should also include establishing a timeline and schedule. I recommend identifying a target date as to when each item should be completed and drafted. I share this schedule with the team, along with who has responsibility for each item.

Remember: Putting together a 510(k) submission is a project.

Review in pieces

Asking your team to review the entire 510(k) submission all at once is a ludicrous idea. Instead, have the team review the submission one part at a time. As each section is drafted, I send it around to the team for review. This allows the preparation process and review process to happen almost entirely in parallel. One major advantage of this technique is being able to stay on schedule and meet the submission deadline. Remember, though, that although reviewing in pieces is helpful, it’s not a complete substitute for a review of the overall 510(k) submission.

Think agile product development methodology applied to 510(k) preparation.

Stay organized

This can be tricky, especially as parts and pieces of your submission are in various stages of completion and review.

If you’ve drafted a 510(k), you know that much of the content is repeated throughout. If something changes in one section, there are many other sections that require updates as well. You have to stay on top of this to stay organized.  

Use RTA as a guide

The first time I had a 510(k) submission go through the FDA’s refuse to accept (RTA) policy, I didn’t like it at all. It took me three attempts to finally get through the RTA step.

The trouble was that I didn’t spend any time really trying to understand the purpose of the RTA process. I didn’t spend any time reviewing the FDA’s RTA checklist—which it definitely makes known and available for free. 

Do yourself a favor and embrace RTA. Use the checklist as a guide and as one of the final checks before you send your 510(k) to the FDA to ensure that everything it expects has been provided.

Here’s one of the reasons I’ve grown to embrace RTA: Approximately two weeks after you submit your 510(k), you’ll get word from the FDA whether the 510(k) has been rejected or accepted for additional review. Prior to RTA, you would submit your 510(k) to the FDA and wait—often months and months—before hearing anything.

Go to a copy center to print the 510(k) for submission

When it comes times to make final preparations and to ship the 510(k) to the FDA, I highly recommend that you go to a copy/document center to have your submission printed. You can try to do it with your desktop printer, but realize the value of copy centers. They are affordable and high value. Assisting with printing, tabulation, and pagination is what they do all day, every day. When you’re well organized, you will likely be able to hand off the task of printing the 510(k) with minimal instructions. It’s worth every penny.

Of course, when the copy center completes the printing project, give the submission one final check before boxing and shipping it.

When you use these six tips, the chance of having your 510(k) submission rejected will be reduced dramatically.

First published on the greenlight.guru blog.


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.