De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff

De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff





The De Novo process provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness for the device, but for which there is no legally marketed predicate device. 

Today, the U.S. Food and Drug Administration (FDA) released a final guidance document on the De Novo Classification Process (Evaluation of Automatic Class III Designation). The purpose of this guidance is to provide updated recommendations for interacting with the FDA, including what information to submit when seeking a path to market via the De Novo classification process. This guidance replaces “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,” dated February 19, 1998. 

This guidance was issued in draft on August 13, 2014.  The final version:

• provides additional details to clarify descriptions of the De Novo classification process
• explains that in the situation where a company first submits a 510(k), the 21st Century Cures Act removed the requirement that a De Novo request be submitted within 30 days of receiving a not substantially equivalent (NSE) determination

Also today, the FDA released draft guidance on the Acceptance Review for De Novo Classification Requests. This draft guidance explains the procedures and criteria that the FDA intends to use in assessing whether a De Novo classification request is sufficiently complete for the Agency to undertake a substantive review.  It includes checklists to help identify the necessary elements and contents of a complete application.  With the enactment of MDUFA IV, FDA agreed to issue draft (and final) guidance that includes a submission checklist to facilitate a more efficient and timely review process to assist with new performance goals.  The comment period for this guidance will be open for 60 days. This draft guidance is not final nor in effect at this time.    

For additional information about the De Novo process, see Evaluation of Automatic Class III Designation (De Novo Classification Requests).

WEBINAR: On November 21, the FDA will host a webinar for industry to discuss and answer questions about the final guidance document, “De Novo Classification Process (Evaluation of Automatic Class III Designation) and the draft guidance document, “Acceptance Review for De Novo Classification Requests.” FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required.

• Date: November 21, 2017
• Time: 1:00 – 2:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 888-603-9072, International Callers Dial: 1-415-228-5032; Conference Number: PWXW5928261; Passcode: 6375834
• To view the slide presentation during the webinar:  https://www.mymeetings.com/nc/join.php?i=PWXW5928261&p=6375834&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at:http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.  For assistance with a specific De Novo request, please contact Sergio de del Castillo at 301-796