FDA update October 3, 2011

Draft Guidance for Industry and Food and Drug Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation)

The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet the requirements for clearance under the better-known 510(k) review process.  

FDA is issuing this draft guidance

  • To provide updated recommendations for more efficient interactions with FDA, including what information to submit when seeking a path to market via the de novo process.
  • To provide (1) greater clarity about the suitability of a device for the de novo process, and (2) timely input on the type of data necessary to support de novo classification of a suitable device.

When final, this document will supersede “New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998.

This guidance outlines the two pathways for the de novo process:

  • a pathway that is initiated with a “pre de novo submission” (PDS); or
  • a pathway that is initiated with a 510(k) submission.

A PDS affords you early interaction with us regarding a new device for which you believe there is no predicate device and which you believe is low to moderate risk. For new devices that appear to be suitable for de novo, the PDS pathway also affords you the ability to follow the PDS with a concurrent 510(k) and de novo petition.

  • FDA would  issue a suitability letter within 60 days after receipt of all information necessary to complete the review. The suitability letter will specify whether or not the device appears to be suitable for consideration via the de novo process and, if so, the likely class, likely special controls (if any), and necessary types of performance data. If the device does not appear to be suitable for the de novo process, the non-binding suitability letter will indicate the reasons for this assessment.
  • If at the end of the PDS review, we inform you that the new device appears to be suitable for the de novo process, the next step is for you to concurrently submit both a 510(k) and a de novo petition that should contain the information and data described in the PDS suitability letter. Once FDA sends this suitability letter, there is no time limit for sponsors to collect the information necessary for the concurrent 510(k)/de novo petition submission.
  • Alternatively, you may choose to not submit a PDS. In this case, a de novo petition may be submitted within 30 days after a 510(k) for a device is found NSE. The success of a de novo petition that is filed without a prior PDS will depend on how adequately you identify the risks and special controls (if applicable) and how well you define and collect adequate data to provide reasonable assurance of safety and effectiveness.
  • Note that a PDS should not be submitted once a 510(k) has been submitted, unless we specifically advise you to do so.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2011-D-0689

Or you can send your comments to, within 90 Days, info@mdiconsultants.com and REF: New draft guidance De Novo Classification Process.

For more information on this guidance you can go to the following link:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM273903.pdf