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# CDRH Webinar Explains 2 De Novo Guidances
- URL: https://www.fdaweb.com/cdrh-webinar-explains-2-de-novo-guidances/
- Published: 2017-11-30T12:00:00.000Z
- Updated: 2026-09-14T23:04:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140236

A CDRH 11/21 [webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm582518.htm?ref=fdaweb.com) described two guidances relating to the *de novo* program. A final guidance, *De Novo Classification Process (Evaluation of Automatic Class III Designation*, provides updated recommendations for interacting with FDA, including what information to submit when seeking a path to market via the *de novo* classification process. A draft guidance, *Acceptance Review for De Novo Classification Requests*, is not in effect, but is available for comment.

CDRH Office of Device Evaluation *de novo* program lead **Sergio de del Castillo** said the finalized guidance summarizes the legal foundation for *de novo* classification and the significant statutory changes that have occurred over time and that affected the *de novo* program.

De del Castillo reviewed the guidance eligibility section, saying it is one of the most key areas sponsors should be concerned about in determining whether a product is eligible for *de novo* classification.

Devices going through the *de novo* process must not have a predicate and cannot fit into any existing Class 1, 2, or 3 classification regulation. “Earlier interaction with the agency can be beneficial to both you and the agency when determining whether or not something is in fact appropriate for *de novo* classification,” he said. “And we can do that through our pre-submission process. If, in fact, we determine that the product is appropriate for *de novo* classification, it would also be a great opportunity to identify the valid scientific evidence that would be needed to support your future *de novo* request.”

Referring to the draft guidance, de del Castillo said that when finalized, it would ensure that a *de novo* request meets a minimum threshold of administrative completeness so FDA could conduct a substantive review. He said the *de novo* submission checklist in the guidance is very similar to that for 510(k)s and PMAs.