On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway.  In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway.  Effectively, the Proposed Rule could help manufacturers of new and innovative medical devices overcome difficult but necessary 510(k) pre-market notification hurdles endemic in FDA’s Class I and Class II medical device review processes.

Generally, FDA classifies medical devices into either Class I (low-risk), Class II (moderate-risk) or Class III (high-risk, requiring costly pre-market approval) depending upon the safety and effectiveness of the medical device.  However, medical devices developed after May 28, 1976 (i.e., post amendment devices) are automatically classified into Class III, unless the device manufacturer shows the new device is substantially equivalent to a device(s) already on the market (predicate devices) in either Class I or Class II (the FDA 510(k) Process).  If the manufacturer proves substantial equivalence, the manufacturer’s device may be classified in either Class I or Class II, which require less manufacturer time and cost associated with product development and market oversight obligations.

However, new devices are sometimes so advanced that predicate devices cannot be adequately compared to the new device for purposes of proving substantial equivalence.  In these cases, manufacturers of new or novel medical devices may encounter significant and costly regulatory hurdles associated with the FDA 510(k) Process and generally risk having their new low- to moderate-risk device fall into Class III.

In 1997, Congress created the de novo review pathway to assist medical device manufacturers experiencing predicate device comparison problems.  In short, the de novo process allows manufacturers to request FDA issue a classification opinion as to whether the manufacturer’s new or novel device is low- to moderate-risk and therefore eligible for Class I or Class II classification.  The de novo process essentially permits FDA to classify a new medical device as either Class I or Class II without requiring the manufacturer to prove substantial equivalence to older, less advanced Class I or Class II devices.  Nevertheless, the de novo process has been complicated by rather unclear standards and procedures and review criteria. 

Seeking to improve the process, FDA’s Proposed Rule aims to make the following changes to the de novo pathway process:

1. Clarifying procedures and requirements for submitting de novo requests;

2. Establishing a regulatory framework that sets clear standards, expectations, and processes for FDA de novo review and classification;

3. Creating a procedural framework for FDA’s granting and declining of de novo applications, as well as manufacturer’s withdrawal of de novo applications;

4. Maintaining confidentiality of a manufacturer’s de novo application until FDA has issued an order granting or declining the de novo request;

5. Establishing a standard set of content that must be submitted with each de novo application to help facilitate FDA’s review of the de novo request; and

6. Creating procedures to govern FDA’s review and ultimate acceptance of a de novo application.

In effect, FDA’s proposed changes to the de novo pathway will require more and more device manufacturers to rely on the de novo process to gain market clearance for new and novel medical devices. Manufacturers should be cognizant de novo review may inadvertently assist competitor manufacturers in pursuit of clearance through the FDA 510(k) Process for substantially equivalent products.