Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs
In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs. Recently, the […]
[FEATURED] QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo
For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft […]
Risk Benefit Analysis and Residual Risk are Key Components of ISO 14971:2019
Author: Nupur Srivastava, PhD | December 7, 2020 The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is […]
