Dec 5, 2018


  • US FDA has proposed formal policies and criteria for De Novo novel medical device classification requests.
  • The De Novo classification route allows some low- and moderate-risk devices for which substantial equivalence cannot be established to obtain US market access.
  • The proposed rules would set a 120-day review period for De Novo classification requests.

Medical device regulators at the US Food and Drug Administration have proposed a more formalized and clarifying approach to registration requirements for devices qualifying for De Novo classification.

A new proposed rule from FDA would set criteria and procedures for De Novo device classification under US Medical Device Classification Procedures (21 CFR Part 860); the De Novo pathway covers low- and moderate-risk devices incorporating novel technologies or components, and for which substantial equivalence under 510(k) premarket notification requirements cannot be established. The De Novo pathway allows US market access for novel devices that would otherwise have to undergo more rigorous Premarket Approval (PMA) premarket review before commercialization.

Under Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA began assessing user fees for De Novo submissions for the first time for its 2018 fiscal year.

Components of the proposed De Novo registration rules

The proposed rule would establish the following processes for De Novo application submissions and withdrawals, with provisions for protecting proprietary device information:

  • De Novo submissions are accepted for devices that have previously received not substantially equivalent (NSE) determinations for 510(k) applications.
  • Applicants may submit De Novo requests without first utilizing the 510(k) submission route if they determine there are no suitable predicate devices for their products on the US market.
  • FDA reviewers will classify De Novo submissions according to US law and via written order within 120 days of receiving submissions.
  • De Novo requests should include:
    • Administrative information and regulatory history
    • Device description
    • Classification summary information
    • Device benefits and risks
    • Performance data demonstrating reasonable assurance of safety and effectiveness
  • FDA Refuse to Accept (RTA) policies may be used for ineligible or incomplete De Novo submissions.
  • FDA substantive review of De Novo requests will result in requests for additional information, approval or denial of requests.

In addition, De Novo requests may include recommendations to FDA reviewers as to whether devices in question should be considered Class I or Class II, and should include explanations for why general and/or general and special controls are appropriate indicators of reasonable assurances of safety and effectiveness for these devices.

“The statutory language on the content of De Novo requests is vague regarding what specific information is expected from the requester,” states FDA in its proposed rule. “With codified minimum content requirements, industry will be better able to anticipate what is necessary for successful De Novo classification, and FDA staff will have clear standards for the content and process for De Novo classification.”

Welcome clarification after steep De Novo fee increases

The new FDA proposed rule follows the agency’s setting of substantial user fees for De Novo requests in 2017 as well as performance goals for assessing such requests. Providing clarification and greater detail regarding De Novo device classification requests should help US market applicants better determine whether to utilize this registration pathway given its significant cost.

Additional US FDA medical device regulatory resources:

  • US FDA 510(k) consulting for medical device and IVD companies
  • US FDA medical device and IVD regulatory strategy
  • FDA medical device classification consulting
  • FDA Pre-Sub (Q-Sub) consulting for medical device manufacturers
  • Whitepaper: US FDA regulations for novel and innovative products
  • Whitepaper: Determining substantial equivalence for FDA 510(k) clearance


  • Stewart Eisenhart