The National Evaluation System for Health Technology (NEST) is a program the FDA is using to generate better real-world evidence to guide their decision-making around medical devices. NEST aims to actively surveil medical devices already on the market to quickly identify risks to patients using data from sources like clinical registries and electronic health records. This system will benefit medical device manufacturers by allowing them to identify safety issues in real-time and reduce the costs of post-market surveillance while allowing the FDA to develop more flexible regulatory models tailored to technologies. In 2019, Congress provided further funding to continue developing NEST's active surveillance capabilities.

1. NEST – Improving the Regulatory Process
for Medical Devices
By: Madison Wheeler
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and
Radiological Health (CDRH) is constantly striving towards. Among several other programs
introduced or changed over the past couple years, the National Evaluation System for Health
Technology (NEST) is a program the FDA is building upon to generate better real-world
evidence to guide their decision-making around medical devices.i
The idea of NEST was first developed in 2012 and has since been built upon to increase
its capabilities. A large part of the program is active surveillance of medical devices, that are
already on the market, to quickly identify risks to patients. For example, continuously using
algorithms to evaluate device performance and safety data in routine clinical practice. Data
sources will come from real-world data (RWD) sources such as clinical registries, electronic
health records, and medical billing claims which the FDA will integrate into their pre- and post-
market decision making processes for medical devices.ii
So, what does this mean for medical device manufacturers? There are a couple of key objectives
of the national system using active surveillance that will benefit medical device manufacturers:iii
1. Manufacturers will be able to identify safety signals in real-time, thus making their risk
management and product development programs more robust.
2. Reduced cost of medical device post-market surveillance.
3. FDA will be able to develop flexible regulatory models that fit to the technology rather
than trying to fit the technology through a “one size fits all regulatory pathway…”. This
will provide a streamlined clearance and approval of new devices, or new uses for
existing devices.
Overall, NEST aims to work with all members of the medical device ecosystem (device
manufacturers, regulators, health systems, etc.) to efficiently leverage real-world data to increase
safety and accelerate development and research of medical devices.iv In 2019, Congress provided
funding to continue developing NEST’s active surveillance capabilities.
Need help understanding the medical device regulations? Contact us at 248-987-4497 or email us
at info@emmainternational.com.

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i FDA (August 2019) National Evaluation Systemfor health Technology (NEST) retrieved on 09/04/2019 from
https://www.fda.gov/about-fda/cdrh-reports/national-evaluation-system-health-technology-nest
ii FDA (June 2019) Statement on agency’s efforts to increasetransparency in medical devicereportingretrieved on
09/04/2019 from https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-
transparency-medical-device-reporting
iii Shuren (October 2018) FDA Perspective on NEST [PowerPoint slides] retrieved on 09/04/2019 from
http://mdepinet.org/wp-content/uploads/MDEpiNet-Annual-Meeting-Slides-Day-2.pdf
iv NESTcc Governing Committee (August 2018) NEST CoordinatingCenter (NESTcc) Charter retrieved on
09/04/2019 from https://nestcc.org/wp-content/uploads/2018/09/NESTcc-Charter_v2.7-Final.pdf