by Sophia Rubalcaba, Senior Regulatory & Quality Affairs Project Director
What is the De Novo Classification Process?
The De Novo classification process, also known as “Evaluation of Automatic Class III Designation,” is a device classification process that allows FDA to classify new devices that are not equivalent to an existing Class I or Class II device and would otherwise be automatically classified as a Class III device [Section 513(f)(1 ) of the FD&C Act)], regardless of the device risks or the ability to demonstrate general or special controls.
How has the De Novo Classification Process Evolved?
The De Novo classification process was established in 1997 following modifications to the Food, Drug and Cosmetic Act (FD&C Act) under the Food and Drug Administration (FDA) Modernization Act (also referred to as FDAMA) incorporating Section 513(f)(2) of the FD&C Act. The new section of the act allows companies to submit a De Novo request only after submitting a 510(k) and receiving an FDA decision of “not substantially equivalent” to a predicate device. Following submission of the De Novo request, FDA would then decide whether to classify a device from a Class III to Class I or II with a new classification/regulation.
In 2012, a provision was added to Section 513(f)(2) following additional modifications of the FD&C Act made through the Food and Drug Administration Safety and Innovation Act (FDASIA). The intent of this new provision was to streamline and increase efficiency of the De Novo process by creating an alternative path for submitting a request for De Novo classification without requiring prior submission of a 510(k) and establishing a statutory 120-day timeframe for review of the request. Recent policy and procedural changes have implemented a 150-day review performance goal.
Recent De Novo Process Policy and Procedural Changes
Implementation of User Fees
The Medical Device User Fee Amendments of 2017 (MDUFA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorized FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2017. This includes most De Novo requests. The only applicable exceptions apply to submissions for a device intended solely for a pediatric population (section 738(a)(2)(B)(v)(I) of the FD&C Act) and for state or federal government entities submitting devices that will not be commercially distributed (see section 738(a)(2)(B)(iii) of the FD&C Act). The De Novo Classification User Fees, implemented to enable FDA to improve the medical device review process and assist FDA in meeting performance goals, defines a Standard fee of $93,299 and a Small Business fee of $23,307.
Release of De Novo Related Guidance Documents
In October, FDA released three final guidance documents and one draft guidance document associated with the De Novo process.
1. Guidance for Industry and Food and Drug Administration Staff (Issued on October 2, 2017), User Fees and Refunds for De Novo Classification Requests. This guidance document addresses frequently asked questions and is intended to describe the types of De Novo requests subject to user fees, exceptions to user fees, and actions that may result in refund of user fees that have been paid.
2. FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals, Guidance for Industry and Food and Drug Administration Staff (Issued on October 2, 2017). This guidance document describes:
- The different FDA actions that may be taken on De Novo requests (grant the request, decline the request, request additional information (AI), or issue a notice of withdrawal).
- Defines a performance goal review timeframe (150 days) and goals under MDUFA IV for De Novo requests received in fiscal years 2018-2022 as well as communication process if a final decision has not been rendered within 180 days.
- The different industry actions that may be taken on De Novo requests (i.e. respond to an AI request or withdrawal of the De Novo request).
3. De Novo Classification Process (Evaluation of Automatic Class III Designation, Guidance for Industry and Food and Drug Administration Staff (Issued on October 30, 2017). This document replaces the draft version issued on August 14, 2014 and supersedes the previous guidance, New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff dated February 19, 1998. The guidance document provides recommendations for the following:
- When the De Novo Classification Process may/may not be used.
- The two mechanisms for submitting a De Novo Request for FDA Review (Pre-Submission and De Novo Request with/without a preceding 510(k)).
- Information/content that should be included in a Pre-Submission (including recommendations for when it should be submitted) or De Novo Request.
- Address for De Novo Requests.
- Additionally, this guidance provides an overview of the FDA Review Process for De Novo Requests.
4. Acceptance Review for De Novo Classification Requests, Draft Guidance for Industry and Food and Drug Administration Staff (Issued on October 30, 2017). This draft document explains the procedures and criteria FDA intends to use in the agency’s assessment of whether a De Novo Request meets minimum requirements to be accepted for review by the agency, including the process for Notifications of Acceptance Review Result or Refuse to Accept Principles. The review policies and procedures will allow FDA to review “complete De Novo requests” in order to increase efficiently and meet MDUFA IV performance goals. Included within the draft guidance is the Acceptance Checklist for De Novo Classification requests.
RCRI has regulatory experts that can help you through the entire De Novo Classification Process. Contact Samantha Thrun at email@example.com or 952-224-2260 to set up a call.