Analyzing De Novo Devices

by | Oct 19, 2020 | De Novo, FDA, Medical Devices, Quality, Regulatory

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn allows similar devices to leverage the De Novo device as a predicate. In recent years, the De Novo pathway has proven to become much more popular among manufacturers. According to the FDA’s latest MDUFA quarterly report, the agency has cleared 41 De Novo devices during the fiscal year 2020 (as of June 30) alone, which is almost the entire amount of De Novo accepted devices between 1997 and 2012.1 With its increase in popularity, the pathway has also seen an increase in criticism. Many institutions believe there is not enough scrutiny of these devices considering they can set the predicate for comparable devices, and therefore have regulatory implications beyond just the De Novo devices.

To investigate, researchers at JAMA Internal Medicine analyzed 65 moderate-risk therapeutic devices cleared via De Novo between 2011 to 2019. Of the 65, 12 had been cleared without going through clinical trials. Additionally, 17 devices had missed at least one primary efficacy endpoint, which at a high-level means that the devices had failed to prove efficiency or meet a specific criterion of the clinical trial.2 Despite this data, none of the 65 devices were the subject of recalls. The authors of the study acknowledged that they did not investigate any voluntary post-market studies on these devices and therefore may only be looking at a portion of the evidence for device safety and efficiency.

It is important to note that this study does not suggest that medical devices cleared via De Novo are unsafe or ineffective. Rather, it is evidence of the issue with De Novo that the FDA is already working to address, that the requirements for the pathway are not as clear or transparent as they could be. The agency is working on finalizing a rule on the De Novo process that would establish procedures and criteria for the pathway, making it more transparent for manufacturers and patients. These established procedures and criteria would allow for a more efficient process for manufacturers, and a clearer picture of device safety and efficiency data for the public.3

The De Novo pathway reduces regulatory burden by providing a more efficient path for novel devices to get to market without having to automatically go through the Class III process. Subsequently, the pathway allows novel medical devices to get to patients who need them much quicker than they otherwise would. If you have a device that you are trying to clear via De Novo, EMMA International’s regulatory experts can help you navigate the process. Contact us at info@emmainternational.com or call 248-987-4497 to find out more.


1FDA (Sep 2020) Quarterly MDUFA IV Report retrieved on 10/18/2020 from: https://www.fda.gov/media/142130/download

2Johnston, et al. (Oct 2020) Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019 retrieved on 10/18/2020 from: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2771667?resultClick=1

3FDA (Dec 2018) FDA in Brief retrieved on 10/18/2020 from: https://www.fda.gov/news-events/fda-brief/fda-brief-fda-proposes-improvements-de-novo-pathway-novel-medical-devices-advance-safe-effective-and

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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