U.S. FDA Commissioner Scott Gottlieb, M.D. released a public statement announcing the FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, published on April 17, 2018. The plan – which outlines support for the National Evaluation System for health Technology, including through support to the NEST Coordinating Center (NESTcc) – will focus on five key areas, highlighted below:
- Establish a robust medical device patient safety net in the U.S.;
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations;
- Spur innovation towards safer medical devices;
- Advance medical device cybersecurity; and
- Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
NESTcc is dedicated to its mission to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE), and innovative research.