Medical Devices

Evaluation of Automatic Class III Designation (De Novo)


Introduction

The de novo process provides a pathway to classify a low to moderate risk device for which general controls or general and special controls provide reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. De novo is a risk-based and evidence-based classification process.

Devices that are classified into class I or class II through the de novo process may be marketed and used as predicates for future premarket notification [510(k)] submissions.

Legislative History

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process.  These devices remain in class III and require premarket approval unless the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent to a predicate device that does not require premarket approval, in accordance with section 513(i) of the FD&C Act. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the de novo classification pathway under section 513(f)(2) of the FD&C Act, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act.

In 2012, section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for de novo classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k).

A De Novo Request

There are two options for de novo classification for new devices of low to moderate risk that are not substantially equivalent to an existing class I or class II device and for which general or general and special controls are sufficient to ensure a reasonable assurance of safety and effectiveness.

  • Option 1: Any sponsor who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a de novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
  • Option 2: Any sponsor who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

The following information should be included in a de novo request per the guidance document New Section 513(f)(2) – Evaluation of Automatic Class III Designation Guidance for Industry and CDRH Staff:

  • A coversheet clearly identifying the request as a “Request for Evaluation of Automatic Class III Designation” under 513(f)(2) or de novo request.
  • The 510(k) number under which the device was found not substantially equivalent (if applicable).
  • A statement of cross reference to the information contained in a 510(k) (if applicable).
  • The classification being recommended under section 513 of the Act.
  • A discussion of the potential benefits of the device when compared to the potential or anticipated risks when the device is used as intended.
  • A complete discussion of the proposed general and/or special controls to ensure reasonable assurance of the safety and effectiveness of the device, including whether the product should be exempt from premarket review under section 510(k) and what special controls, if proposing a Class II designation, would allow the Agency to conclude the device is reasonably likely to be safe and effective for its intended use.
  • Any clinical or nonclinical data that are relevant to ensure reasonable assurance of the safety and effectiveness of the device.

Submitting a De Novo Request

There is no user fee associated with the submission or review of a de novo request.

De novo requests must be submitted in an electronic format (eCopy). FDA does NOT return the de novo request after review. You should retain a copy of your de novo for your records.

Requests should be sent to the appropriate Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

We recommend submitting the de novo to FDA by a method that will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service.

When CDRH receives a de novo, it assigns the request a unique document number. The de novo number begins with “DEN” followed by six digits. The first two digits represent the calendar year in which the request was received and the last four digits represent the sequential request number for that year. For example, the first de novo request received in the calendar year 2015 would be DEN150001. CDRH will provide an acknowledgment letter, including the de novo number, within one week of CDRH’s receipt of the de novo request. 

For de novo submissions for the Center for Biologics Evaluation and Research (CBER) please contact them for further assistance at either 1-800-835-4709 or Industry.Biologics@fda.hhs.gov.

De Novo Decisions

The FDA goal to make a final decision for a de novo classification is 120 days.

If a de novo request is granted:

  • the new device is legally marketed and must be in compliance with applicable regulatory controls;
  • the new device establishes a new classification regulation;
  • the new device may now serve as a predicate device for 510(k) submissions of future devices;
  • FDA publishes in the Federal Register an order that announces the new classification regulation and, for class II devices, the new special controls;
  • FDA posts on its website a copy of the Order notifying the sponsor that we have granted marketing authorization; and
  • FDA generates and publically discloses a decision summary.

Since 2010, the FDA has published decision summary documents for devices classified through the de novo process. The de novo decision summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for FDA’s decision to grant a de novo request. The de novo decisionsummary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate.

This information is publically available in the de novo database and also published on the CDRH Transparency website “Evaluation of Automatic Class III Designation (De Novo) Summaries.”

Page Last Updated: 03/14/2017
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