The U.S. FDA recently issued a draft Guidance document setting forth a streamlined, improved de novo petition process for medical devices. Currently, when the FDA rejects a medical device manufacturer’s 510(k) notification as not substantially equivalent to a lawfully-marketed predicate device, the manufacturer has 30 days to file a de novo petition seeking to have the device placed in Class I or II and must then await a ruling. If the FDA denies the de novo petition, or the manufacturer opts not to file one, to secure marketing approval the manufacturer must pursue a costly and time-consuming pre-market approval (PMA) application. The recently-issued draft Guidance proposes to allow the manufacturer to file a 510(k) notification and contingent de novo petition at the same time, so that if the 510(k) notification is not approved, FDA will rule upon the de novo petition shortly thereafter.
FDA classifies medical devices according to risk, with Class I being the lowest risk and Class III being the highest. Devices of a new type that FDA has not already classified fall into Class III by statute. As a result, at one time the FDA had to approve a PMA application for such devices before they could be marketed legally. Congress created the de novo petition process as an alternative to the PMA application in the Food and Drug Administration Modernization Act (FDAMA) of 1997. The de novo petition process allows low to moderate risk devices to be placed into Class I or II and thus marketed without going through the PMA process. The draft Guidance states, in an epic understatement, that the FDA believes the de novo process “has been under-utilized because of process inefficiencies.” To FDA’s credit, the draft Guidance seeks to remedy the situation by describing a mechanism “to provide (1) greater clarity about the suitability of a device for the de novo process, and (2)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.”
As noted above, the mechanism allows the concurrent filing of a 510(k) notification and a de novo petition. Prior to that filing and potentially early in the development process, however, the draft Guidance identifies a new pathway that begins with a “pre de novo submission” (PDS). For a device the manufacturer believes may lack a predicate, the PDS allows FDA to analyze the suitability of the device for a de novo petition and to provide the manufacturer with advice on the documentation, including evidence, that will be needed for the concurrent 510(k) submission and de novo petition. The draft Guidance helpfully includes a three page Attachment describing the information a PDS should contain. Thus, the PDS pathway offers an opportunity for early interaction with, and feedback from, the FDA on the information needed to secure marketing approval by one of two means for a device, potentially saving the manufacturer considerable time and expense by helping to ensure that the manufacturer gathers and submits the necessary data and only the necessary data.