But Wait! Are you even ready for Regulatory Submission?
This page may be the one you landed on, but the story doesn’t start here. If you haven’t read how to get started, visit our timeline page to find out how we help companies like yours traverse concept to commercialization. Don’t rush past the important steps and attempt submission without the necessary prerequisites, or you will end up a poor Madman while the Medman successfully gets their medical device to market.
What Are the Steps to Regulatory Submission?
Define Your Product
What is the intended use of your medical device? What are the indications for use?
Verify Your Product is a Medical Device
Is your product actually a medical device? Do you need help determining, this?
Determine Class and Pathway
Without properly determining the proper FDA classification for your product, it is difficult to identify the best pathway to take to market. Plus, determining just the FDA class can help tell you a lot about your product.
Develop Valid Scientific Evidence
You will have to gather the proper evidence to prove your product works and will succeed in the market. If determining how to gather this information feels overwhelming and you don’t know where to start, remember the leanRAQA team has helped accomplish this for our clients time and time again and we can do the same for you!
FREE Conversations with the FDA through Q-submissions
Get the best bang for your buck by not spending any. Unlike other markets, your submission goes directly to a government agency in the U.S. The FDA’s Q-submission program encourages early engagement with the industry and includes:
Pre-submissions
The holy grail of free FDA communications, pre-submissions are an easy
way to get clarity from the FDA. With over 3,000 submitted to the FDA
each year, this is the most popular Q-submission, and for good reason.
Pre-submissions are a great advantage to get feedback on your clinical
protocol, predicate strategy, testing, and more.
Breakthrough Device Designation (BDD)
For companies with cutting-edge, life-saving technology, you may want to consider applying for a Breakthrough Device Designation. Technologies designated as Breakthrough get insane perks, such as shorter pre-submission turnaround times, clinical protocol agreements, and data development plans. Get to market faster by having more FDA resources dedicated to your company’s technology and ultimate success!
Safer Technologies Program (STeP)
The younger sibling to BDD, STeP is a fairly new FDA program aimed to address the technology that doesn’t quite meet the requirements of Breakthrough. This program focuses on safety alternatives to existing technology. And you’ll get the same advantages identified above! Not bad for free, huh?
Premarket Submission
Not to be confused with a Pre-submission! A premarket submission is a required submission to the FDA before you commercialize your device. If the previous steps were training for a race, this is the step where we need to decide which type of race you and your medical device qualify for. Will we be running a 5K, a half marathon, or a full marathon? Unfortunately, the decision won’t be yours–instead, the FDA will tell you which you HAVE to run.
Types of Regulatory Submissions
510(k) – The 5k Race
510(k) applications are for low and moderate-risk devices. This category includes traditional, abbreviated, and special 510(k) classifications. 510(k) submissions are the lowest-cost FDA submission type, so we try our best to help keep our clients in this category.
De Novo – The Half Marathon
De Novo applications are for devices that have no existing classification regulation or clear predicate. In other words, novel devices. De Novo requires more time and money to get your product to market when compared to 510(k) submissions.
PMA – The Full Marathon
PMA submissions are the highest-cost submission type and take the longest time to process. If PMA is avoidable, leanRAQA has the map to the shortcut.
Get Fluent in FDA Dialect with the Help of leanRAQA
What is the difference between FDA clearance, approved, and listed?
If you want to impress your investors, go the extra mile and learn to talk the talk. Know that if you submit a 510(k), it is cleared. Only devices undergoing the PMA process get approved. A de Novo 510(k) gets approved to be cleared. For low-risk devices not requiring a pre-market submission, the device is only considered listed once your company registers. Is your head spinning yet? leanRAQA can do the talking so you don’t have to, and we’ll make you look like you know it all while we’re at it.
What Comes After Regulatory Submission?
If done correctly, submissions should be followed by clearance. But the race doesn’t stop there! Next comes the market, Quality Management Systems (QMS), compliance, audits… luckily for you, the leanRAQA team can help in these areas as well.
So… You Don’t Think You Need Help With Your Regulatory Submission?
I mean, you do your own taxes, and you’re not an expert in US tax law, right?
I mean, sure. But if you don’t find, read, and correctly interpret every applicable regulation, how do you know what you’re missing? And we know from experience that the FDA, the EU MDR, and other notified bodies don’t take kindly to missed deadlines.
Every year the FDA produces more than:
- 400 pages of published guidance documents
- 250 pages of draft guidance documents
- Many pages of consensus standards
- 205 pages of the MDSAP audit guide, plus the companion guide
- 25 pages of ISO 13485:2016
- 225 pages of the ISO 13485 Practical Guide to Implementation
That’s a LOT of reading.
You Don’t Need Help With MDR, Either
If you’re planning on marketing your product in Europe and elsewhere, add these to the mix:
- 175 pages and 11 annexes in the MDR
- Separate medical device regulation for the UK
- Separate medical device regulation for Switzerland
- Individual medical device regulation for other non-EU countries
- Pages and pages of harmonized EU standards
This is where the rubber hits the road, my friends, because that’s more than 1,000 pages of regulations.
Sure, you can find a checklist on some random blog, address those items, cross your fingers, and hope you chose well.
But is that really the best strategy?
Nobody has time for that.
You have more productive things to do, so let us page through the documents to find the regulations, standards, and guidances that apply to your product.
We do dozens of FDA and EU MDR regulatory submissions every year, across multiple markets. No matter your get-to-market plans, we can help you craft a successful regulatory submission.
Give us a call. Let us do the regulatory heavy lifting: Perhaps the best decision you make today.
Avoid These Common Mistakes
A few do’s and don’ts and you’re there – easy peasy.
1. Don’t undercommunicate with the FDA – if you need to submit a pre-submission, just do it
2. Don’t overcommunicate – don’t hand the FDA three pre-submissions when one will do, especially if two of them are unusable
3. Unblock your ears – and listen to what the FDA is telling you
4. Don’t mimic your competitors – worry about your regulatory submission, not theirs, and develop your own regulatory strategy
5. Don’t try to use political favor or connections to sway the FDA – nuff said.
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.
