The U.S. Food and Drug Administration has proposed updated procedures for its de novo medical device approval pathway in an effort to speed up the process and inspire more device makers to innovate.

The FDA's de novo pathway is an expedited approval process that allows low- to moderate-risk devices to enter the market when a comparable, or predicate, device is not already approved. This pathway falls between the other two device pathways in terms of its level of scrutiny and time spent in regulation. When the device comes with more risk, it undergoes a more stringent version of the de novo process called premarket approval. When a "substantially equivalent" device has already been approved, new similar devices follow the more common 510(k) process.

Proposed changes to the de novo pathway would "provide structure, clarity and transparency" to the process, the FDA said in a Dec. 4 statement. The changes relate to the format and content of de novo requests and clarify the ways in which they are accepted, granted, declined or withdrawn.

"Our goal is to make the de novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review," FDA Commissioner Scott Gottlieb said in a statement. "As a result, we expect to see more developers take advantage of the de novo pathway for novel devices."

One of the proposed changes would remove the requirement that a device maker must first apply for a 510(k) approval. The changes will also facilitate classification and clarify when and how the FDA will decide which devices deserve approval.

Cowen analyst Eric Assaraf said in a Dec. 4 policy note that the FDA intends to spur greater use of the de novo pathway by clarifying the process. The proposed changes are part of the agency's "ambitious regulatory reform plan to promote speedier access to innovative devices and diagnostics," Assaraf wrote. The firm expects the reform agenda to continue in 2019.

"In our view, more transparency and predictability for de novo applications is good for industry," Assaraf said. "However, first filers may still be apprehensive of utilizing the pathway as it paves the way for competitors to bring products to market under a simple 510(k)."

The FDA also said in late November that it is considering changes to the 510(k) approval pathway. According to the regulator, 82% of all devices cleared or approved by the agency in 2017 followed the 510(k) path. Those changes would require device makers to compare new products to more modern devices when seeking approval, making it more difficult for them to prove equivalence to the devices already on the market.