lunes, 20 de noviembre de 2017

REMINDER: Webinar 11/21: De Novo Classification Process (Evaluation of Automatic Class III Designation)

On November 21, the FDA will host a webinar for industry to discuss and answer questions about the De Novo program.  On 10/27/17, the FDA posted final guidance document 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.  The FDA also posted draft guidance on Acceptance Review for De Novo Classification Requests that is not final and not in effect at this time.

Webinar Details:

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:

Following the webinar, a transcript, audio recording, and slides will be available at: The slide presentation will also be available at this site on the morning of the webinar.

As always, we appreciate your feedback; following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience. The survey can be found  immediately following the conclusion of the live webinar.

NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.

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  For assistance with a specific De Novo request, please contact Sergio de del Castillo at 301-796-6419

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