ARTICLE SUMMARY:
Less than half of devices that pursued FDA’s De Novo classification as a route to market in recent years have had success as firms struggle to prove effectiveness for their novel low-to-moderate risk technologies. Advice from a CDRH official and expert consultant on the best ways for companies to build rapport and gain buy-in from reviewers and to take advantage of opportunities to win the benefit-risk balance with the help of postmarket planning.
FDA’s De Novo classification framework can offer a helpful middle ground for some outside-the-box medtech innovations, but it is no walk in the park. Hundreds of novel low- to moderate-risk devices have taken the De Novo route to market. However, in a typical year, more devices fail than succeed on this regulatory pathway.
The device industry has taken note of the sub-50% success rate for De Novo reviews in recent years (see Figure 1), compared to the 80%-90% authorization rate for 510(k)s and PMAs. Industry and FDA are likely to discuss possible De Novo reforms during the MDUFA VI user fee reauthorization talks that are just getting underway, as the industry presses for more predictability and consistency.
Joshua Nipper, a leader in CDRH’s premarket device program, is all for improving the De Novo process, but he points out that there are inherent challenges with De Novos based on the nature of the companies and devices that pursue the pathway.
