11 Sep NEST – Improving the Regulatory Process for Medical Devices
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.1
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.2
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:3
- Manufacturers will be able to identify safety signals in real-time, thus making their risk management and product development programs more robust.
- Reduced cost of medical device post-market surveillance.
- 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.4In 2019, Congress provided funding to continue developing NEST’s active surveillance capabilities.
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1FDA (August 2019) National Evaluation System for health Technology (NEST) retrieved on 09/04/2019 from https://www.fda.gov/about-fda/cdrh-reports/national-evaluation-system-health-technology-nest
2FDA (June 2019) Statement on agency’s efforts to increase transparency in medical device reporting retrieved on 09/04/2019 from https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting
3Shuren (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
4NESTcc Governing Committee (August 2018) NEST Coordinating Center (NESTcc) Charter retrieved on 09/04/2019 from https://nestcc.org/wp-content/uploads/2018/09/NESTcc-Charter_v2.7-Final.pdf