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Webinar Materials

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On November 21, the FDA hosted 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 The FDA also posted draft guidance on Acceptance Review for De Novo Classification Requests that is not final and not in effect at this time.

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