FDA proposes improvements to the De Novo pathway

Departments - Regulatory

Simplified medical device classification procedures; FDA working to combat opioid crisis

February 4, 2019

The U.S. Food and Drug Administration (FDA) published the De Novo Classification Proposed Rule which, if finalized, would establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures (21 CFR Part 860).

The De Novo pathway reviews novel, low- to moderate-risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to determine substantial equivalence.

The proposed rule builds on FDA’s earlier work to provide structure, clarity, and transparency to the De Novo classification pathway.

“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,” says FDA Commissioner Scott Gottlieb, M.D. He adds that the FDA is modernizing the 510(k) pathway for clearance of low- to moderate-risk devices that are substantially equivalent to devices already on the market.

“The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances,” Gottlieb says.

The proposed rule is available for public comment and will not be in effect until finalized.

Simplified medical device classification procedures

In early Dec. 2018, the FDA issued a final rule simplifying its procedures for classifying and reclassifying medical devices. The final rule clarifies that it can reclassify any device from Class III higher-risk devices; automatically assigned by law in lieu of classification orders to either Class I or Class II.

Aligning regulations through the FDA Safety and Innovation Act of 2012 through the final rule allows the agency to reclassify a post-amendments device or a transitional device by publishing an administrative order in the Federal Register.

The final rule also removes the requirement to provide two forms because, according to the agency, the FDA “no longer finds the forms useful.”


FDA working to combat opioid crisis

The FDA newly launched FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder seeks to spur development of medical devices. More than 250 applications from medical device developers led to the selection of eight challenge participants. Proposed devices predict the risk of opioid use disorder (OUD), detect opioid overdose, dispense medication, and provide pain treatment alternatives to opioids.

Selected applicants will work with FDA regulators to accelerate development and marketing application review of innovative products, similar to the Breakthrough Devices Program. The process’ collaboration phase starts before the end of March 2019 with goals to:

  • Create mutual understanding of device target product profile
  • Identify patient, user needs; risks, benefits
  • Discuss potential regulatory pathways