ABOUT FDA'S 510K
Your device. Our expertise...
THE 510K PATHWAY
In the United Sates, medical devices fall into three classes based on risk:
Class 1 - Low risk (cotton swabs, hospital beds)
Class 2 - Medium risk (x-ray, denture resins)
Class 3 - High risk (blood thinners, pacemakers)
As a general rule, manufacturers and importers of Class 2 devices must file a 510(k) Premarket Notification and receive clearance from FDA before marketing their products. Some novel devices follow the De Novo pathway instead.
HOW LONG IT TAKES
FDA takes 90 days to review a 510(k) submission. Add 30 days for preparation of the document and responses to reviewer questions, and the minimum time to receive clearance is four (4) months. Add to that however long it takes you to assemble requested information, including product testing.
As its name implies, FDA 510k Consultants does but one thing--510k submissions. Our competitors brag about offering a broad range of regulatory services. We find it better to focus solely on what you need--510k clearance, registration, listing, and expert advice on product testing.
WHAT IT COSTS
You will pay three regulatory costs to clear your medical device. The first is FDA's "user" fee to review the submission (about $5,000). The second is any third-party charges to test your product. This typically represents your biggest expense, with the cost higher if the device is powered or sterilized.
The third regulatory cost is our consulting fee. We're not the most expensive nor the cheapest, but we do generally save clients money because the only services we provide are directly related to clearance of your device through FDA. That means we're more efficient than most.
"We recently developed a medical device fabricated by 3D lithographic printer. John was so intent on making sure we cleared this new technology that he flew to FDA headquarters in Silver Spring, MD, to attend a two-day public symposium on 3D printing. That dedication, at no extra charge to us, resulted in our device being the first permanent 3D-printed dental device cleared by FDA."
Jason L., Principal Scentist, USA