De Novo Pathway Challenges and Opportunities
Researchers from universities in three countries say the FDA medical device de novo pathway “holds significant potential for innovators seeking to define new categories of novel medical devices, as well as for FDA to modernize the 510(k) pathway by promoting reliance on modern device predicates that represent a more accurate reflection of the state-of-the-art technology and current standards of safety and effectiveness.” Writing in the open source npj Digital Medicine, the authors say the de novo pathway was created by Congress in the 1997 FDA Modernization Act to foster the development of innovative medical devices by providing an intermediate pathway between a 510(k) and a PMA application.
The new pathway was rarely used in the first 15 years of its existence, the article says, partly because it was not available to manufacturers directly. The FDA Safety and Innovation Act of 2012 gave the agency the authority to review direct de novo submissions. But it wasn’t until FDA issued guidances in 2017 and 2019 that the use of the pathway increased.
The researchers say that ideally, de novo requests “should capture innovation at the device category level, while 510(k) clearances would capture the continuous improvement innovations taking place at the device level. They say the current levels of activity indicate that about 1% of medical device innovations are at the category level, while 99% stem from continuous improvement in medical devices.
The article says that future use of the de novo pathway will depend in part on how FDA defines “substantially equivalent” as part of the 510(k) process. If the agency continues the current practice of granting 510(k) clearances by stretching and broadly interpreting the original 1976 categories and predicates, manufacturers will continue to use that pathway because, on average, it is a faster path to market.
The authors say that sophisticated applicants with valuable intellectual property and valuable clinical data at high evidence performance standards may see de novo as a strategic opportunity to (1) define an entirely new category of medical devices; (2) influence the special controls required for the category; (3) establish their device as the first predicate in the category; and (4) potentially amplify the value of their core patents.