One of the most frequent questions MDCI fields from new medical device companies relates to the FDA’s “De Novo” process.  In fact, they get so many inquiries about the De Novo process that they put together this post that addresses the history and function of the process and offers some guidance regarding its viability as path to market for medical device manufacturers.  It’s not as easy as it seems.

The De Novo process has been around since the implementation of the FDA Modernization Act of 1997 (FDAMA). The FDAMA was intended to improve the efficiency of bringing low-risk medical devices to market, allowing for simpler reclassification of devices that were classified as Class III  due to the lack of a suitable predicate.  Section 513(f)(2), the section of the FDAMA that handled this particular aspect of medical device classification, became known as the “De Novo” process.

De Novo is a 2-step process that requires a company to submit a 510(k) and complete a standard review, including an analysis of the risk to the operator associate and patient with the use of the device and the substantial equivalence rationale. Once that has been accomplished, and the medical device in question has been determined to be Not Substantially Equivalent (NSE) by the FDA, the product is automatically classified as a Class III device. Then, the manufacturer can submit a request for evaluation of Automatic Class III designation to have the product reclassified from Class III into Class I or Class II.

The FDA will review the device classification proposal and either recommend special controls to create a new Class I or II device classification or determine that the product is a Class III device.  If FDA determines that the level of risk associated with the use of the device is appropriate for a Class II or Class I designation, then the product can be cleared as a 510(k) and FDA will issue a new classification regulation and product code. This also adds the device in question to the predicate pool, which in turn expands the market for other medical device companies considering products in a similar therapeutic area. If the device is not approved through De Novo, then it must go through the standard premarket approval (PMA) process for Class III devices.

The number of FDA NSE determinations due to the lack of a suitable predicate is quite low for those low risk medical devices that have the potential for reaching the market via the De Novo process.  Medical device manufacturers are attracted to the cost efficiencies associated with the De Novo process when compared against the investment and post-market FDA oversight associated with a PMA. Unfortunately, the time to market for devices eligible for the De Novo process can be very long.

FDAMA calls for the FDA to review and return a decision on a De Novo reclassification submission within 60 days of receipt (the initial submission must be sent by the manufacturer within 30 days of receiving NSE notification). In practice, however, the amount of time taken to review De Novo requests by the FDA and issue the special controls guidance  has risen significantly from 62 days in 2006 to 241 days since 2007. Tacked on to the 510(k) review times, devices traveling the De Novo pathway average a whopping 482 days of review time from start to finish.

Beyond the delays associated with De Novo, the fact that the entire process resembles a procedural “black hole” is difficult.  The FDA is not required to provide any updates concerning the status of a De Novo application, nor is there any viable mechanism for medical device manufacturers to track a De Novo submission on their own.

De Novo is indeed quite rare in the realm of low-risk medical devices – a mere 54 products took this particular route between 1998 and 2009 – less than 5 products per year. Given the extensive delays associated with the process, MDCI advises medical device companies to consider all other market approval pathways before deciding to pursue a De Novo reclassification.

Prepared by Benjamin Hunting, Cindy Nolte, and Helen Mayfield

republished and adapted with permission from MDCI

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