FDA Proposes Improving De Novo Pathway

Posted December 11, 2018

As part of its effort to modernize the premarket review of medical devices, the Food and Drug Administration (FDA) has proposed a new rule for its De Novo classification pathway in an attempt to make it more “significantly more efficient and transparent,” according to FDA Commissioner Scott Gottlieb.

The De Novo pathway, which was established in 1997, provides a way for new technologies to obtain marketing authorization as a Class I or II medical device rather than automatically receiving a Class III designation and being subject to premarket approval, regardless of risk level.

If finalized, the FDA said its De Novo Classification Proposed Rule would  “provide structure, clarity, and transparency on the De Novo classification process.”

“The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," Gottlieb said in a statement. “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.”

According to the proposed rule, a De Novo request would include a medical device’s administrative information, regulatory history, device description, classification summary information, benefits and risks of device use, and performance data to demonstrate a “reasonable assurance of safety and effectiveness.” Once received, the FDA would provide a written classification for the device within 120 days.

Devices cleared through the De Novo pathway become predicate devices that can be used in future 510(k) submissions, which is used to clear low- to moderate-risk devices that are substantially equivalent to a device already on the market. With the FDA recently announcing the possibility of major changes to its 510(k) clearance process, the agency said it expects the number of submissions to the De Novo program to increase—and provide a “vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances.”

“The proposed regulation … will help the FDA regulate new technologies in ways that enable us to protect patient safety while promoting innovations that can advance peoples’ health and function,” Gottlieb said.

The FDA is seeking feedback on the proposed rule at www.regulations.gov until March 7.