What 2019 Data Reveals About FDA’s 510(k) Program

2020-bl-brandwood-fda-501k-trends-page-imageGiven the U.S. Food and Drug Administration’s (FDA) ambitious objective to simplify and achieve more predictability in medical device regulation, it’s only fitting to take a closer look at 510(k) pathway activities in 2019.

There are so many questions to ask: Are more 510(k)s being approved and are they taking longer? What countries did most of the 510(k) applications come from in 2019? What were the top product codes receiving 510(k) clearances in 2019?

In this article, we’ll explore 2019 trends in 510(k) clearances and what these may be saying about the evolving industry.

Prior Use of 510(k)

Our recent coverage on this topic includes a webinar on the 510(k) modernization initiatives. In addition, we also recently hosted the FDA discussing one of their latest initiatives: the Case for Quality which was kicked-off by the FDA with a comprehensive report issued in October 2011 titled “Understanding Barriers to Medical Device Quality”. This report provided some great insights into trends for medical devices in the U.S. beginning in 2011. 

The report concluded that enforcement activities were not adequately aligning industry activity with the objective of improving the quality of medical devices. Furthermore, it recommended a new collaborative approach to reduce the historical “whack-a-mole” (a term the FDA used to suggest a reactionary method of enforcement), which emphasized compliance over improvement. 

At our consultancy, we always say information is power and this report outlines some insights that may be valuable to device makers planning for 510(k) clearances. 

Below are some interesting figures from the 2011 report:


The 2011 FDA report shows medical device sales grew in the U.S. by 9% each year (per anum, p.a.) while the number of 510(k) clearances declined each year by 2%. This could mean that market players are growing their sales without necessarily commercializing new technologies.

Interestingly, even though revenues in device sales continued to increase, the rate of patients injured in serious events also continued to climb. This may indicate that possibility that higher revenues in the field were not being translated into improvements that would lead to safer products.

Overall, the 2011 report from FDA highlighted the following needs:

• Align compliance focus to address industry quality needs. 
• Enhance transparency and visibility of FDA data to drive quality.
• Increase industry engagement.  

The report concluded that “investment by [the] FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well-made as they are innovative.”

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More recently, in the FDA’s 2018-2020 Strategic Priorities Report published January 2018, the agency stated that one of its top measures of success for 2020 would be that:
“By December 31, 2020, more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets.”

In the report, the FDA designated novel technologies to include premarket approval (PMA), panel track supplements, De Novo, humanitarian device exemptions or a premarket notification 510(k) under the Breakthrough Devices Program.  

That FDA benchmark object that sums up the aims of of the Strategic Priorities intended to make the U.S. regulatory framework more attractive for medical device innovators. The goal of increasing by 50% the number of 510(k) applications applying in the U.S. by the end of 2020 would be a significant increase from a baseline of 4% anticipated in the 2011 launch of the program, according to a Northwestern University study. The study also found that 80% of devices in 2011 were being launched first in Europe, a trend that is expected to be impacted by the recent Medical Device Regulation (MDR)/In Vitro Device Regulation (IVDR) challenges in Europe. 


510(k) Clearances in 2019

Since Class II devices (which represent 80% of all devices) are governed by the 510(k) clearance program, we’ll focus our analysis on 510(k) application data to get a better pulse of the industry. Using the FDA 510(k) Clearances Releasable Databases, we’ll address the following questions:  

• Are more 510(k)s being approved in 2019? Are they taking longer?
• What countries did most of the 510(k) applications come from in 2019?
• What were the top product codes receiving 510(k) clearances in 2019?

#1. Are more 510(k)s being approved in 2019, and are they taking longer?

As the analysis below shows, the number of approvals has remained at about the same annual rate. To eliminate the possibility that there has been a change in number of applications, we reviewed the number of applications submitted per year which has remained relatively stable at about 3,000 per year. 

The number of days from application submission to an FDA decision has fluctuated between 145 and 160 days since 2013. Further, since 2013, there hasn’t been a significant change in the number of days between receipt of the 510(k) application and decision. 

#2. From which countries did most of the 510(k) applications come from in 2019?

Consistent with historical levels in 2019, the vast majority of 510(k)s (58%) list their filing address from the U.S. Moreover, 97% of the total 510(k) products reviewed by the FDA in 2019 originated from only 20 countries. A breakdown of 510(k)s by country shows the relative amount of medical device innovation happening in each country and the volume of medical technologies being developed and marketed in each country.


3. What were the top product codes receiving 510(k) clearances in 2019?

The chart below outlines the top 510(k) cleared product codes issued in 2019. At the top of the list was “System, Image Processing, Radiological,” which falls in line with the trend of increased number of software-based medical devices. The overall distribution of product codes for 510(k)s remains very diversified with 737 different 510(k) product codes applied for in 2019. 



The FDA’s ambitious goal to simplify the regulatory process and achieve more predictability in medical device regulation is a worthwhile objective. Coupled with smarter enforcement expected to be realized from initiatives like the Case for Quality and the Digital Health Software Precertification (Pre-Cert) programs, the FDA hopes to make progress toward that objective. The timing seems ideal considering that challenges stemming from MDR/IVDR implementation, including the shortage of accredited notified bodies, in Europe may cause medical innovators to rethink their go-to-market strategy.

As for 2019, 510(k) pathway approval times and number of applications in the U.S. seems to have plateaued with 97% of applications coming from a cohort of 20 countries. We’ve also seen the number of 510(k)s issued for diagnostic and software-based products increasing, a trend that is expected to continue.

Can the FDA’s fully realize its objectives with the 510(k) and related programs? Time will tell, but it appears the agency is making no small amount of efforts in streamlining and harmonizing regulatory reviews of medical devices.

2020-bl-author-luis-jimenezLuis Jimenez serves as the vice president of business development for Brandwood CKC. His experience includes operations, quality control in CGMP manufacturing, regulatory affairs for manufacturing, design engineering, technology transfer and project management within a start-up and large corporations such as Johnson & Johnson and Express Scripts. Jimenez’s background includes chemical engineering, cum laude, with focuses on computer science and economics, and an MBA with academic excellence. His trajectory in diverse health-related companies and experience building a Class III medical device biotech company from the ground up provides him with hands-on experience in solving the challenges of navigating regulatory approvals. Jimenez is passionate about entrepreneurship and regulatory issues and serves as the 2020 president for the Orange County Regulatory Affairs Group (OCRA).