FDA recommends “modernizing” review of devices in wake of global investigationBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5026 (Published 27 November 2018) Cite this as: BMJ 2018;363:k5026
- Jeanne Lenzer, associate editor
- The BMJ
The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.
The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.1
Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) …