FDA Issues Draft De Novo Guidance Incorporating FDASIA Modifications

By Jennifer D. Newberger –

On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). 

The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act), as amended.  This process was added to the FDC Act by the Food and Drug Administration Modernization Act of 1997 (FDAMA) to address novel devices that lack a predicate device but pose only a low to moderate risk, making them ill suited to the PMA process. 

Under FDAMA, before a device could utilize the de novo process, a device first had to be found not substantially equivalent (NSE) to a predicate device through the 510(k) process, even if the submitter and FDA agreed no appropriate predicate existed.  Due to the burdensome, time consuming nature of the de novo process, it was under utilized.

In September 2011, FDA issued a draft guidance document attempting to streamline the de novo process.  We discussed this draft guidance here.  Under that draft guidance, a person could submit a 510(k) and de novo petition simultaneously, and FDA could begin review of the de novo petition immediately upon issuance of the NSE letter. 

In July 2012, Congress amended section 513(f)(2) through passage of the Food and Drug Administration Safety and Innovation Act (FDASIA).  Under section 607 of FDASIA, a finding of NSE is not required before submitting a de novo petition.  Instead, if a person believes the device is low to moderate risk but no appropriate predicate exists, the person may submit a de novo without previously submitting a 510(k).  With the passage of FDASIA, the draft guidance issued in September 2011 was essentially mooted. 

The latest draft guidance describes the process of submitting a de novo petition under FDASIA, focusing primarily on the information to include in a de novo petition or a request for a Pre-Submission meeting prior to submitting a de novo request.  The information to include in a de novo petition includes the following: 

• a recommendation whether the device should be regulated as Class I or Class II;
• whether the device should be subject to 510(k) requirements;
• if a Class II device subject to 510(k), the petition should include a proposed special controls document, describing the intended use, risks, and risk mitigation strategy for the device;
• supporting protocols and data;
• a summary of benefits and known and potential risks; and 
• risk and mitigation information. 

In addition, the submission must include a “classification summary” demonstrating that the submitter has thoroughly researched legally marketed devices and concluded that no appropriate predicate exists.  To demonstrate that the submitter conducted such a search, the de novo submission should include:

• a description of the databases searched and terms used to establish no predicate exists; 
• regulations, PMAs, and/or product codes that may relate to or are potentially similar to the subject device; and 
• a rationale for why the subject device does not fit within or is different from the identified regulations, PMAs, and/or product codes. 

The draft guidance states that if a submission fails to include this information, it will be put on hold.

While it seems appropriate for a submitter to demonstrate that it has conducted a reasonable search and concluded that no appropriate predicate exists, there is a potential for overly burdensome implementation of these search requirements by FDA.  If FDA places a de novo submission on hold after concluding that insufficient information has been provided, FDA should help guide the submitter in searching for or identifying information FDA believes may be relevant.

The de novo process has long been in need of remediation.  FDASIA provided the basis for that remediation, and the guidance should help industry take advantage of this process.  Hopefully this more streamlined process will allow innovative, moderate risk devices to more easily enter the marketplace.