US FDA to Modernize 510(k), De Novo Review Processes for Medical Devices

The US FDA plans to modernize the 510(k) and De Novo pathways for reviewing new medical devices.

The 510(k) pathway, established in 1976, compares new technology with predicate, or existing, devices. More than a fifth of devices are compared with predicate devices more than 10 years old, according to the FDA, and this may be holding back innovation.

Commissioner Scott Gottlieb, MD, announced Nov. 26 that the 510(k) program would shift its focus to using modern predicate devices or objective performance criteria. 

In 2017, the FDA used the 510(k) pathway to clear 3,173 devices, or 82 percent of the total devices cleared or approved.

The De Novo pathway, set up in 1997, is designed to review novel, low- to moderate-risk devices without a predicate as a class I or class II device. It also provides a way to establish new predicate devices.

Gottlieb said Dec. 4 that the agency will make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and processes for review.

He said the agency expects more developers to take advantage of the De Novo pathway, especially as the 510(k) process evolves.

The FDA has approved a total of 235 De Novo marketing authorizations for medical devices, with 170 occurring after 2012.