But fast-track designation still may not be the best path to market.
On September 14, 2023, FDA watchers were scrambling to parse new guidance issued by the FDA regarding their Breakthrough Devices Program.
The exciting news: there are now even more ways to qualify as a Breakthrough Device. The caveat: the final number of devices that qualify and actually make it to market are still surprisingly low.
We break down the pros and cons of the new rules of the road.
What is The Breakthrough Device Program?
Established in 2015, the Breakthrough designation was meant to cut red tape and help get life-saving technologies to market, fast. Or as the FDA says, in order to bring “innovative products to patients in need” (full memo here).
*Through 3/23. Source, FDA Data, MedTech Insight.
There are 2 main criteria for gaining Breakthrough designation:
Source: FDA
Advantages of Breakthrough Device Program
The data shows that devices designated as Breakthrough have a MUCH shorter review period, almost cutting the time in half.
For 510k-cleared devices in the Breakthrough category, review time was 155 days vs. 270 days for other 510k-cleared devices.
DeNovo was even similarly eye-popping: review periods were 251 days vs. 338 days (source).
Another potential advantage that may soon become a reality is if Bill H.R. 1691 becomes law, CMS will be required to provide reimbursement for devices designated as breakthrough. That can be a very strong financial incentive to attempt to attain this designation.
What’s the Catch?
839 devices have been prioritized by the FDA’s Breakthrough device program. The bad news is that only a small percentage of them have made it to market — 81 devices, which is less than 10%.
But…what about the other 90%? Some speculate that the FDA holds prioritized device to a higher evidentiary standard, and devices that might have made it through the standard process, don’t here.
Or medical device start-ups who believe to they can bring a fast-tracked device to market on a shoe-string budget ultimately run out of funding.
Bottom line: Breakthrough designation may not be right for every device.
What Does the New Guidance Say?
Overall, it’s good news for medical device makers, as the FDA’s new guidance broadens the definition of which devices may qualify, such as non-addictive devices that treat pain or addiction. Additionally, if you can prove that your device promotes health equity for under-served populations — now your device may qualify.
One more gem: when considering if a device meets the first criterion (device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions), the FDA will now consider accessibility of the device, when determining if it is more effective that standard of care.
Should I try for Breakthrough Designation?
Every situation is different, and a lot may depend on the category of device, your timeline, and device’s safety profile.
Our team is highly experienced, with over decades of experience guiding medical device manufacturers through the FDA regulatory process, and 80 products successfully brought to market.
The best way to get started is to book a free consultation with one of our regulatory experts. PTL will customize a path to market for your device that considers safety, speed, and budget.
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