De-Mystifiying the De Novo Process

De-Mystifiying the De Novo Process

The De Novo process was first introduced in 1997 with the implementation of the FDA’s Modernization Act (FDAMA). [1] It was meant as a means to reclassify novel devices of low to moderate risk profiles that were automatically deemed Class III because no substantially equivalent devices existed to merit a successful 510(k) submission. At first glance the process seems to be a convenient method of reclassifying a device from III to II or I and gaining approval to market the device. If this is the case, then why is it that as of September 2010, only 54 devices had been approved through the de novo pathway? [2]

signWhen the De Novo process first came to be, sponsors had to first submit a 510(k) and receive an NSE (Not Substantially Equivalent) determination from the FDA. They then had to convert the application to a de novo submission. On July 9, 2012, section 513(f)(2) of the FD&C was amended to allow sponsors to request a de novo classification without first submitting a 510(k). [3] While this was a step in the right direction, the de novo process still remains shrouded in mystery and pit falls. The goal here is to establish a better understanding of the process, its upsides and downsides, and when it is the right option.

The Good

Before the De Novo Process was developed, sponsors had no alternative option to a PMA if no predicate existed. The PMA process is a lengthy one that can be very costly, and for devices of low to moderate risk profiles, unnecessary. Also, now that sponsors no longer have to submit a 510(k) and wait for a decision of NSE, it would be assumed that the process is straight forward and there is less time from submission to approval.

The Bad

DuVal and Associates issued a Client Alert in May 2013 regarding the de novo petition. They metaphorically referred to the De Novo process at the “Big Bad Wolf”; making the Sponsor the “Little Red Riding Hoods” who fall prey to the wolf’s trickery. DuVal warns that the FDA may use the de novo process as an escape valve for the 510(k) program when an agreement on substantial equivalence can’t be reached. The reason the FDA favors the de novo pathway is because “the offer for a de novo “out” is often a way for the FDA to justify a request for additional data, including animal and clinical data.” [5]

This does seem to be a condemnation of the process; however it is substantiated by the fact that up to 2007 the de novo review time was 62 days, with an overall review time of 245 days (including the 510(k) application and review). Ever since 2007, the average de novo review period has increased to 240 days, with a total of 482 review days. It must be noted that these numbers were calculated before the de novo process was reformed in 2012. [6]

The Process



conclusionThe final question “Is the de novo process right for my product?” can be answered by meeting the following criteria; if your product 1) is a novel device (new intended use) and, 2) presents a moderate or low risk profile, and 3) no predicates exist (with the same intended use), de novo may be the right option. This is conditional on your ability to provide the necessary evidence supporting the safety and effectiveness of the device, including the general and/or special controls which would provide a reasonable assurance of safety and effectiveness to the FDA. A decision to go down the de novo pathway should be made on a case by case basis. Boston Biomedical Associates can help to make this determination. BBA provides the experience and knowledge necessary to successfully navigate the murky waters of the de novo process.


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[1] B. Hunting, C. Nolte and H. Mayfield, “What You Don’t Know About De Novo – A Primer For Medical Device Companies,” Aptiv Solution Medical Device Blog, 2011.

[2] E. Merce, “De novo device reclassification: What have you done for me lately?,” Ask Cato – The official Blog of Cato Research, 2012.

[3] O. o. M. P. a. Tobacco, “Evaluation of Automatic Class III Designation (De Novo) Summaries,” 2014.

[4] F. Staff, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” October 3, 2011.

[5] P. DuVal & Associates, “DuVal Client Alert — Little Red Riding Hood and the Big Bad Wolf: Beware of De Novo,” 2013.

[6] Z. I. M. Ladin, “FDA Review Patterns of ‘De Novo’ Submissions,” 2010.

Mack Rubley


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