Posted by Michael Wonder on 30 Jul 2019
Moving from substantial equivalence to substantial improvement for 510(k) ddevevices
29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems.
A 2018 Netflix documentary, The Bleeding Edge, highlighted multiple such medical devices, 2 of which, Essure (a device for female sterilization) and transvaginal mesh for pelvic organ prolapse, were taken off the market after the film’s release. Recent Kaiser Health News stories reported that more than 1 million medical device adverse event reports had been sealed from public view by the US FDA.
The New York Times recently called for reforms in device regulation in an editorial entitled “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.”
