What is a 510(k)?
The FDA defines their 510(k) submission as “a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.” In other words, it is a comparison of your device to an already proven device. If you plan on marketing a new medical device in the United States, you will be required to submit a 510(k) – that is, if you don’t qualify as 510(k) exempt or require a de novo or PMA.
The process takes some time, so your regulatory strategy should plan for ample hours to complete writing it and gathering all of the necessary testing and clinical reports as needed. Officially, the FDA takes about 90 calendar days to review your submission. Still, it could potentially be placed on hold via a Request for Additional Information (RAI or AI), which pauses the clock and lengthens the entire process. Without professional help, you and your device could too easily get caught up in one of these roadblocks and completely fall off the path to market. Don’t let yourself become a cautionary tale. Hire the experts at leanRAQA to keep you on the right track to success.
Who needs to 510(k) Anyway?
Before we jump into planning for a 510(k) submission, the first step is determining whether 510(k) applies to you and your medical device or if you are 510(k) exempt.
Typically, a 510(k) submission is required for class II medical devices–but not always! A special designation exists for some class I medical devices, labeled as “Class I Reserved.” If your device falls in this category, you will still need to complete a 510(k) submission. On the other hand, there are also cases of class II medical devices being 510(k) exempt.
If you haven’t already, check out our Regulatory Strategy page for more information on how to determine your device’s product code and regulation. From there, we can tell you if the 510(k) is an appropriate pathway to market for your device.
Ready to discuss your options? Go ahead, put some time on my calendar. Or, continue reading the information on our site to learn how easy RAQA can be with the leanTeam, then put some time on my calendar. Either way, let’s talk.
So YOU need a 510(k)… Now what?
If you are still reading this page, you have probably determined that you need to file a 510(k). On your own, the road ahead may seem daunting–with the leanTeam by your side, we can “keep calm and 510(k) on” down the easiest road possible.
If you have started researching the pathway to 510(k) submissions, you may already be familiar with terms such as predicate device, substantial equivalence, novel devices, De-Novo, predicate selection, reference device, etc. Whether you have a strong understanding of these terms, somewhat of an understanding, or absolutely no understanding, the leanTeam is here to help.
With all the different splits in the road that these terms present, it’s crucial to have a strong, clear strategy for getting to the finish line. You COULD attempt to develop this strategy on your own based on your research… or you could let leanRAQA show you a thing or two about the industry we consider ourselves experts in. (Psst! leanRAQA has developed countless regulatory strategies for our client’s different needs over our many years of experience, and we have found several “shortcuts” and “detours” along the way. Hire us for your regulatory strategy needs, and we’ll share our improved roadmap to easy 510(k) submissions!)
The 510(k) Types and Which One Applies to your Medical Device
Over our many years of experience in the RAQA world, we have discovered that for many, determining which type of 510(k) submission your medical device needs adds another layer of confusion to the entire 510(k) process. The FDA categorizes 510(k) submissions into four groups: Traditional, Abbreviated, Abbreviated Safety and Performance, and Special. Although most medical devices fall into the traditional category, special circumstances exist for each of the other options. Take the guesswork out of determining which type of 510(k) you should submit. Let the leanRAQA team tell you which one is right for your medical device.
510(k) Summaries… What’s that?
510(k) summaries are publicly available on the FDA 510(k) premarket notification database. They are NOT the entire 510(k)! They are instead precisely what the name entails – a summary. When the FDA reviews your 510(k) submission, they look at more than just the summary. The process includes reviewing your testing, design, labeling, and other documents to see the whole picture. In fact, 510(k) submissions in their entirety are often hundreds, if not thousands, of pages long. Are you already thinking, “I don’t have time for all this!”? Well, lucky for you, the leanRAQA team does have time to help you with all of this. Scratch it all from your to-do list and replace it with one simple task: Meet with Michelle and the leanRAQA team.
The leanRAQA Team Speaks FDA So You Don’t Have To
So you speak English, and the FDA speaks English. It should be a simple conversation, right? Well, think again. The FDA uses a very specific dialect of English, so to speak, and without prior exposure to their vernacular, you may find yourself more confused at the end of the conversation than you were at the beginning. On top of this, every 510(k) submission needs to be written in the FDA’s language for them to interpret; they will be looking for specific phrases and a compelling story that demonstrates you did everything by their book to have a safe and effective device. Lucky for you, the leanRAQA team understands the FDA (and the FDA understands us). Cut down on the workload and stressors of FDA 510(k) submissions, and let the leanTeam do the work for you.
Feeling ready to discuss your options? Go ahead and put some time on my calendar to schedule a chat. (We promise to speak with language you understand.)
Two Submission Pathways Diverge in a Wood…..Do You Know Which Path to Take?
Download my FREE Regulatory Pathway Assessment tool, which walks you through the specifics of choosing a regulatory submission pathway.
Then pick an open half hour on my calendar and we can chat about your regulatory submission needs.
