Congratulations, you’ve received your 510(k) clearance from the U.S. Food and Drug Administration (FDA)! You’ve worked for weeks, months, perhaps even years to get to this point, and I’m sure you can’t imagine working on one more plan – but you do need a marketing plan for your FDA clearance.
You and a team of researchers, engineers, scientists, developers, clinicians and countless others put so much into your product and this clearance process. You’ve conducted clinical trials, filled out applications and assembled hundreds or thousands of documents, making for some very long days and late nights. Some equate the clearance process to raising a child – challenging, exhausting, fulfilling and wonderful.
After all that hard work, it might be tempting to coast now that the finish line is in sight, but resist the urge. It’s tempting to not want to take on one more thing at this time, but you must now that your product is available on the market.
Wait, what is FDA 510(k) clearance anyway?
Didn’t “Last Week Tonight” host John Oliver once say it didn’t mean much? Yes, as a matter of fact, he did, and yes, as a matter of fact, he’s wrong.
The 510(k) clearance is a premarket submission made to the FDA that demonstrates the product’s safety and efficacy. In the words of the FDA: “Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”
The length and intensity of the process varies based on the class of device. This is not a scientific definition by any means (for that, refer to the FDA), but a good rule of thumb is anything that delivers anything into a human body takes a good bit of scrutiny.
One of the companies we’ve helped with marketing and media outreach to announce their FDA clearance is Ivenix, a Massachusetts-based medical technology company that was the first – and only – large-volume infusion pump cleared under more stringent guidelines the FDA established five years ago. Their years-long journey involved more than 50,000 pages of documentation and results of thousands of hours of testing.
Ivenix CTO George Gray said about the process: “We had to demonstrate that our pump was safe under all conditions. Similar to other 510(k) clearance processes, we had to demonstrate the safety and efficacy of a predicate device, but the FDA challenged us to improve in those areas where they historically saw safety issues in the other infusion pumps, not just the predicate device we referenced.”
Will you be ready to announce your clearance news?
We’ve had clients who received clearance in a few weeks to a few months. It really depends on the device and what it’s doing in relation to a human being. But regardless of whether you’re fast-tracked or facing a longer haul for approval, what are you going to do once you receive it?
Some believe the day they receive FDA clearance their phones will start ringing, both from reporters and prospective customers. That’s typically not how it …read more
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