FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus on the following five major areas: Establish a robust medical device patient safety net in the United States by improving the quality and reliability of real-world evidence that manufacturers assess to support the safety and effectiveness of their products. Explore regulatory options to streamline and modernize timely implementation of post-market mitigations. Spur innovation toward safer medical devices. Advance medical device cybersecurity. Integrate the Center for Devices and Radiological Health’s (CDRH) pre-market and post-market offices and activities to advance the use of a TPLC approach to device safety. The Action Plan builds…

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