“starting from the beginning; anew”
A key tenet of the 1997 Food and Drug Administration Modernization Act (FDAMA) was the creation of the De Novo pathway for medical device accreditation. The De Novo pathway was designed to enable streamlined and timely classification of low-to-moderate risk ‘novel’ medical devices as Class I or II, removing the necessity for provisional class III status and subsequent Pre-Market Approval.
The FDA system of classification and market approval has always relied on predicate technologies and products to inform new accreditation. The De Novo pathway, similar in sentiment to the EU CE marking method, is about device-specific risk and rule assessment rather than precedent.
Despite almost yearly modernisation initiatives since the watershed Food, Drug and Cosmetic Act of 2012 (FD&C), debate still rages as to whether the pathway is truly fit for purpose. In January 2018, the Center for Devices and Radiological Health (CDRH) set an ambitious target to have 50% of all manufactured novel devices come to the US first, or in parallel with other major markets. Doubtless, the pathway has come a long way since 1997, but how realistic has this ambition been? Let’s chart the developments of De Novo and from the evidence, draw some conclusions as to whether the CDRH target is a real possibility or just a commendable idea.
An Inauspicious Start
The De Novo pathway was created to streamline the classification of novel class I & II devices. However, for the first 15 or so years into implementation, it was little more than a well-intentioned theory given the less than negligible uptake by device sponsors.
Before 2012, the key issue with this so-called time-saving mechanism was that it didn’t save any time at all. In fact, it often took longer than the traditional 510(k) method!
So, what changed?
Prior to 2012, device sponsors looking to submit a De Novo application had to:
- Submit a 510(k)
- Await an FDA decision on the status of the device. If the FDA found the device did not satisfy the conditions of “not substantially equivalent” to a predicate device then the device was classified as Class III and subject to Premarket Approval (PMA).
- If no substantial equivalence is proven, then the sponsor submits a De Novo request
Because device sponsors were forced to begin De Novo by the standard 510(K) submission process, then await an FDA decision on substantial equivalence and still face the prospect of the burdensome PMA at the end of it, there was seemingly no benefit to the far more costly De Novo process versus a traditional application.
In 2012, a new provision to section 513(f)2 of the FD&C Act in concert with additional modifications made through the Food and Drug Administration Safety and Innovation Act (FDASIA) set the De Novo on a new path towards increased uptake.
The intent of the adaptation was to streamline the existing process and increase efficiency through the creation of an alternative path. The new method enabled submission of a De Novo classification without prior submission of a 510(k) and a statutory 120-day timeframe for review of the request.
N.B.: The slightly reduced figure for the first four months of 2019 can be attributed largely to the US government shutdown.
The graphic below demonstrates a clear upward trend in De Novo authorisations since the above outlined changes have been enacted:
The De Novo pathway will continue to evolve in ways legislators feel will entice device sponsors to use it. Still, we can point out some fundamental flaws that will continue to limit the pathway’s ability to contribute to the CDRH’s originally conceived target.
A Paradoxical System
One inherent problem with obtaining De Novo accreditation is that once approved, the device becomes a suitable predicate for device sponsors coming further down the line. De Novo still carries a significantly higher cost than the traditional 510(k) submission, causing many device makers to simply register their device elsewhere and wait for a competitor to bite the bullet in the US and then follow in more cost-effectively afterwards. As the variety and volume of De Novo accreditations steadily increase, this regulation, paradoxically, ends up decelerating and stagnating pathway uptake as device sponsors wait for competitors to go through the process first.
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