By Jon Speer, founder & VP of QA/RA, greenlight.guru
If you are developing a medical device in the United States, there is a good chance your path to market involves a FDA 510(k) submission.
Over my career, I have had a part in putting together several 510(k)s. Within the past year, I’ve had the pleasure of authoring a couple FDA 510(k) submissions on my own from scratch, and I have learned a ton from these most recent FDA 510(k) submissions.
FDA expectations are for 510(k)s are dramatically different from when I started my career. Let me share some things I’ve learned.
RTA Here to Stay
If you are not aware of the current Refuse to Accept (RTA) policy for FDA 510(k) submissions, you should definitely get very familiar.
Basically, RTA is a mechanism FDA now has in place to give you a quick review of your FDA 510(k) submission. Generally speaking, this preliminary review isonlychecking to make sure you have submitted everything FDA expects with the 510(k). It is not supposed to be a review of the actual contents of the 510(k).
An initial reviewer from FDA will go through your submission, following a checklist which is included in the FDA’s RTA guidance document (see page 15). The initial reviewer has 15 days from date your FDA 510(k) was received to provide you feedback on whether or not the submission has been accepted or rejected.
If accepted, you get notification and your 510(k) goes to the next step. If rejected, you will get a copy of the completed RTA checklist, along with comments about any deficiencies noted.
In my two submissions which have gone through this process, both were rejected the first time. And fortunately, the reviewers in both cases were readily available to discuss via phone and email.
Tip #1 - Use The RTA Checklist When Putting Together Your FDA 510(k)
The FDA has provided a guidance document complete with a checklist regarding their Refuse to Accept policy. You should use this to your advantage as much as possible.
I recommend using and completing the checklist as you put together your FDA 510(k) submission. Fill it out citing where each specific question is addressed within the 510(k). Include your version of the RTA checklist with your submission.
No More "I Promise"
Once upon a time, you used to be able to include “I promise” statements with your FDA 510(k) submission for things like sterilization validation, biocompatibility, and electrical safety testing. This is no longer the case.
Tip #2: Complete All Sterilization Validation, Biocompatibility, And Electrical Safety Testing Before Submitting Your FDA 510(k)
You’re going to validate sterilization any way. You might as well and do so prior to submitting the FDA 510(k).
Same rings true for electrical safety testing. Include the protocols, results, and reports.
And biocompatibility ... Once upon a time, you used to be able to leverage existing biocompatibility data for same materials and processes. However, my recent experience indicates this alone is not good enough. You have to have some biocompatibility testing / assessment specific to your product and combination of materials, processes, etc.
Again, provide the protocols, results, and reports.
More, More, More
You used to be able to provide test summaries and results for performance testing. However, it seems FDA has shifted it’s thinking about this. Your FDA 510(k) submission needs to have more than just the summaries.
Tip #3: Include All Test Protocols, Data, And Results
Provide all performance test protocols, performance test data, and performance test results with your submission.
Match Your Predicate
The premise behind FDA 510(k) submission is that your device is substantially equivalent to a predicate device.
The more alike you are to the predicate, the better your case is for 510(k) clearance. However, the more alike you are to the predicate, the less strategic market advantages you have too. It’s a tricky, delicate balance.
Think about it from FDA’s perspective. Their job in reviewing FDA 510(k) submissions is to ensure that you have sufficiently proven that your device is safe and effective.
The best way to do this is to prove head to head and line by line that your product is so similar to a medical device that they have already cleared.
Tip #4: Be As Similar As Possible
Gather as much information as you can about the predicate device you are comparing to. FDA 510(k) summaries available are sometimes lacking in the details you want, so you have to do your homework.
Find marketing literature, instructions for use, and so on about your predicate. Get your hands on the product too.
When you do comparative analysis, perform the testing directly against the predicate. Use the same test methods, standards, etc. Make sure your labeling has the same indications, contraindications, precautions, and warnings as the predicate too.
Regardless, Expect Questions
It’s my opinion and experience that regardless of how thorough and complete your FDA 510(k) submission was, there will be questions from FDA at some point during the review process. Don’t expect your 510(k) to breeze through.
Tip #5: Understand FDA's Questions
When the questions come from FDA, review them promptly with your team. Start to develop an action plan of how you will respond.
There is a good chance that some of the questions provided on your FDA 510(k) are not clear and may be confusing. After you have a preliminary plan, request some time with the FDA reviewer.
I recommend scheduling a call. Provide an agenda and walk through the questions, making sure you understand what FDA expects in response.
Even if you follow these tips, you MUST realize that FDA 510(k) submissions are going to easily take at least six months before getting through all the hoops for clearance. Maybe longer. Make sure you plan accordingly.
About The Author
Jon Speer is the cofounder and VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance, and project management. You can follow him on twitter @creoquality and read all his latest blog posts here, including the comprehensive 13-part series The Ultimate Guide To Design Controls For Medical Device Startups