On October 3, 2011, the Food and Drug Administration (FDA) issued a draft guidance clarifying its “de novo” review procedures and the data required for the submission and review of petitions asking FDA to reclassify certain medical devices currently designated as “Class III.”  

The new draft guidance streamlines the de novo procedure for novel devices by allowing for a “pre de novo submission” (PDS) through which FDA determines in advance whether a medical device is suitable for de novo review. If the PDS is successful (i.e., the agency deems the device is suitable for de novo review), the company may submit a de novo petition and a 510(k) clearance submission concurrently, thus saving time and eliminating uncertainty as to the appropriate route to market for the device. The company must believe that no predicate exists for the new device and that the risk level is low or moderate. The draft guidance also provides for a meeting with the FDA after the PDS has been submitted to discuss the submission’s content and review process. The FDA intends to issue a suitability letter within 60 days of receipt of all the information necessary to complete its review. The key to “suitability” and, thus, to reclassification of the device into Class I or Class II is information sufficient for the FDA to assess whether general or special controls will provide for reasonably safe and effective use of the device.

In the past, companies have either submitted a de novo petition without knowing whether the device is eligible for de novo review, or they have submitted the petition for de novo review after a 510(k) submission response that the device is “not substantially equivalent” (NSE) to a predicate device. The new procedures will eliminate uncertainty as to a device’s eligibility for de novo review before a company files either a de novo petition or a 510(k) and, if the device is eligible for de novo petition review, allow for concurrent filing of the petition and the 510(k). Prior consultations with the FDA also provide guidance concerning the information and data the FDA will expect in a petition and 510(k) premarket notification for the device to ensure that these submissions are as complete as possible when filed and have a better chance for a successful outcome.

Class III is the most highly regulated device category. A device may be Class III because:

  1. The device is novel, not previously classified, and is therefore automatically or statutorily a Class III device;
  2. The device has been found by the FDA through the 510(k) clearance procedure to be “not substantially equivalent” to a predicate device; or
  3. The device falls into a category that the FDA has designated as Class III by regulation.  

Only devices designated as Class III by statutory action (regardless of risk status) and low to moderate risk devices that are found to be “NSE” following a 510(k) submission are eligible for the de novo process. Devices that the FDA has designated as Class III by regulation are not eligible.  

If the FDA grants a de novo petition, the agency intends to make the written order granting the petition and classifying the new device into either Class I or Class II available on the FDA’s website, followed by a regulation and associated Federal Register Notice announcing the device description and classification. A summary of the petition review will also be available on the agency’s website, including a description of any special controls so that companies that want to use the device as a predicate have timely access to the information.

If the de novo petition is not granted, because general or special controls are insufficient to provide reasonable assurance of safety and effectiveness or the information and/or data to support the safety and effectiveness for the intended use are insufficient, the FDA will issue a denial of the petition. The new device will remain in Class III and will require premarket approval before it may be marketed.

Finally, the FDA identifies the following information to be submitted in a de novo petition or a “pre de novo” submission:

  • Applicant information and any regulatory history related to the device;
  • A description of the device, the indication for use and marketing channel (OTC/Rx), target population, and a description of the device’s technological characteristics and components, and directions for use;
  • A classification recommendation and supporting information related to why general and/or special controls are adequate for safe and effective use of the device or information justifying a belief that premarket notification should not be required;
  • Supporting protocols for and/or results of bench and clinical testing, including performance levels and anticipated risks, showing that general or special controls are sufficient to provide reasonable assurance of safety and effectiveness;
  • A summary of the benefits to be provided by the device and information or data about planned and/ or ongoing protocols or studies to support its effectiveness;
  • A summary of known and potential risks to health and any ongoing and/or planned protocols or studies to collect the necessary data to establish the device’s risk profile;
  • Risk and mitigation information in table form showing the identified risk, the recommended mitigation measures (e.g., biocompatibility, labeling, nonclinical testing/analysis or reports to FDA) and the control type each represents (special or general);
  • Device labeling;
  • Special to a Pre-510(k) PDS—a classification summary describing why no predicate exists for the device, why it does not fit an existing device regulation and is not a device type that has been approved in a PMA; and
  • Additional Information Special to a Post – PDS De Novo Petition—a description of all changes since the PDS submission such as changes to the device, test protocols, and/or labeling.  

For a copy of the guidance found on the FDA’s website, please click here.1